Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
// Product Process Validation
{
"resourceType" : "Bundle",
"id" : "bundle-product-process-validation-pq-ex1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "2038e4c7-22b8-4c56-2d28-6c077648763f",
"text" : // validationProtocol
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"2038e4c7-22b8-4c56-2d28-6c077648763f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: DP PROCESS VALIDATION</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#process-validation "Process Validation")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>description</b>: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...</p><blockquote><p><b>action</b></p><p><b>title</b>: Compounding Step</p><p><b>code</b>: Compounding Step <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</a>#compounding)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Compounding Steps</p><p><b>code</b>: Compounding <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filling Steps</p><p><b>code</b>: Filling Step <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</a>#filling)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Lyophilization Step</p><p><b>code</b>: Lyophilization Step <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</a>#lyophilization)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Conclusion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467</code></td></tr><tr><td style=\"display: none\">*</td><td>Homogeneity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467</code></td></tr><tr><td style=\"display: none\">*</td><td>Homogeneity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467</code></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Release Step</p><p><b>code</b>: Release Step <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</a>#release)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f",
"title" : "DP PROCESS VALIDATION",
"type" : // http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq",
"code" : "process-validation",
"display" : "Process Validation"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
},
"description" : "Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...",
"action" : [
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"title" : "Compounding Step",
"code" : // text value="Overall set of actions"/
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "compounding",
"display" : "Compounding Step"
}
]
},
"action" : [
{
"title" : "Compounding Steps",
"code" : // this level is not really needed here, could remove. But in the case where there are different timings, it is needed, so it is here for consistency
{
"text" : "Compounding"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
// ObservationDefinition/compoundingpHPre
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"
},
// ObservationDefinition/compoundingpHPost
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
// ObservationDefinition/compoundingAssayPre
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"
}
]
}
]
},
// ObservationDefinition/compoundingAssayPost
{
"title" : "Filling Steps",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "filling",
"display" : "Filling Step"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Conclusion"
},
"definitionCanonical" : "ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"
},
// ObservationDefinition/conclusion
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424"
},
// ObservationDefinition/TAMC
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"
},
// ObservationDefinition/TYMC
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424"
},
// ObservationDefinition/FillWeightAverage
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424"
},
// ObservationDefinition/FillWeightTarget
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424"
},
// ObservationDefinition/FillWeightAverageFromTarget
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424"
},
// ObservationDefinition/HoldTimeFiltrationToFilling
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424"
},
// ObservationDefinition/HoldTimeFilling
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424"
}
]
}
]
},
// ObservationDefinition/FilterIntegrity
{
"title" : "Lyophilization Step",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "lyophilization",
"display" : "Lyophilization Step"
}
]
},
"action" : [
{
"code" : {
"text" : "Conclusion"
},
"definitionCanonical" : "ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424"
},
// ObservationDefinition/LyophilizationConclusion
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"
},
// ObservationDefinition/LyophilizerNumber
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
// ObservationDefinition/LyophilizationAssay
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467"
},
// ObservationDefinition/LyophilizationWater
{
"code" : {
"text" : "Homogeneity"
},
"definitionCanonical" : "ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467"
},
// ObservationDefinition/LyophilizationWaterHomogeneity
{
"code" : {
"text" : "Homogeneity"
},
"definitionCanonical" : "ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467"
}
]
},
// ObservationDefinition/LyophilizationAssayHomogeneity
{
"title" : "Release Step",
"code" : // text value="Overall set of actions"/
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "release",
"display" : "Release Step"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72"
},
// ObservationDefinition/AppearanceProduct
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72"
},
// ObservationDefinition/AppearanceLyophilized
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72"
},
// ObservationDefinition/AppearanceReconstituted
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"
},
// ObservationDefinition/Identification
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
// ObservationDefinition/Assay
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
// ObservationDefinition/Degradation
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"
},
// ObservationDefinition/Water
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7"
},
// ObservationDefinition/UniformityUSP
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8"
},
// ObservationDefinition/UniformityAcceptance
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72"
}
]
}
]
}
]
}
},
// ObservationDefinition/releasepH
{
"fullUrl" : "urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e72",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fc17b5d5-9fe1-91c2-2d06-47cb5b295e72",
"text" : // compoundingpHPre
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fc17b5d5-9fe1-91c2-2d06-47cb5b295e72\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72</code></p><p><b>title</b>: pH (adjustment of pre-clarification bulk solution)</p><p><b>status</b>: active</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (adjustment of pre-clarification bulk solution))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>6.9-7.1 pH</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72",
"title" : "pH (adjustment of pre-clarification bulk solution)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (adjustment of pre-clarification bulk solution)",
"display" : "pH (adjustment of pre-clarification bulk solution)"
}
],
"text" : "pH (adjustment of pre-clarification bulk solution)"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 6.9,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
},
"high" : {
"value" : 7.1,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e73",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fc17b5d5-9fe1-91c2-2d06-47cb5b295e73",
"text" : // compoundingpHPost
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fc17b5d5-9fe1-91c2-2d06-47cb5b295e73\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fc17b5d5-9fe1-91c2-2d06-47cb5b295e73" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73</code></p><p><b>title</b>: pH (post-dilution bulk solution)</p><p><b>status</b>: active</p><p><b>code</b>: pH (post-dilution bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (post-dilution bulk solution))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>7.0-7.1 pH</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73",
"title" : "pH (post-dilution bulk solution)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (post-dilution bulk solution)",
"display" : "pH (post-dilution bulk solution)"
}
],
"text" : "pH (post-dilution bulk solution)"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 7.0,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
},
"high" : {
"value" : 7.1,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e72",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fd17b5d5-9fe1-91c2-2d06-47cb5b295e72",
"text" : // compoundingAssayPre
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fd17b5d5-9fe1-91c2-2d06-47cb5b295e72\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fd17b5d5-9fe1-91c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72</code></p><p><b>title</b>: Assay (pre-clarification filtration) (mg/mL)</p><p><b>status</b>: active</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (pre-clarification filtration) (mg/mL))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>22-? mg/mL</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72",
"title" : "Assay (pre-clarification filtration) (mg/mL)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (pre-clarification filtration) (mg/mL)",
"display" : "Assay (pre-clarification filtration) (mg/mL)"
}
],
"text" : "Assay (pre-clarification filtration) (mg/mL)"
},
"qualifiedValue" : [
{
"range" : {
"low" : // todo correct this and the others
{
"value" : 22,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e73",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fd17b5d5-9fe1-91c2-2d06-47cb5b295e73",
"text" : // compoundingAssayPost
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fd17b5d5-9fe1-91c2-2d06-47cb5b295e73\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fd17b5d5-9fe1-91c2-2d06-47cb5b295e73" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73</code></p><p><b>title</b>: Assay (Post dilution bulk solution) (mg/mL)</p><p><b>status</b>: active</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (Post dilution bulk solution) (mg/mL))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>20-21 mg/mL</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73",
"title" : "Assay (Post dilution bulk solution) (mg/mL)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (Post dilution bulk solution) (mg/mL)",
"display" : "Assay (Post dilution bulk solution) (mg/mL)"
}
],
"text" : "Assay (Post dilution bulk solution) (mg/mL)"
},
"qualifiedValue" : [
{
"range" : {
"low" : // todo correct this
{
"value" : 20,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
},
"high" : // todo correct this
{
"value" : 21,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fc07b5d5-9fe1-92c2-2d06-47cb5b295e72",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fc07b5d5-9fe1-92c2-2d06-47cb5b295e72",
"text" : // AppearanceProduct
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fc07b5d5-9fe1-92c2-2d06-47cb5b295e72\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fc07b5d5-9fe1-92c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72</code></p><p><b>title</b>: Appearance (Product Container, visual)</p><p><b>status</b>: active</p><p><b>code</b>: Appearance (Product Container, visual) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Appearance (Product Container, visual))</span></p><p><b>method</b>: Visual inspection <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72",
"title" : "Appearance (Product Container, visual)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Appearance (Product Container, visual)",
"display" : "Appearance (Product Container, visual)"
}
],
"text" : "Appearance (Product Container, visual)"
},
"method" : {
"text" : "Visual inspection"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "1) Clear glass vial sealed with a gray rubber stopper and a flip off overseal 2) No visible damage or breach of vial container or closure"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:fc07b5d5-9fe1-92c3-2d16-47cb5b295e72",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fc07b5d5-9fe1-92c3-2d16-47cb5b295e72",
"text" : // AppearanceLyophilized
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fc07b5d5-9fe1-92c3-2d16-47cb5b295e72\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fc07b5d5-9fe1-92c3-2d16-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72</code></p><p><b>title</b>: Appearance (Lyophilized, Visual)</p><p><b>status</b>: active</p><p><b>code</b>: Appearance (Lyophilized, Visual) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Appearance (Lyophilized, Visual))</span></p><p><b>method</b>: Visual inspection <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72",
"title" : "Appearance (Lyophilized, Visual)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Appearance (Lyophilized, Visual)",
"display" : "Appearance (Lyophilized, Visual)"
}
],
"text" : "Appearance (Lyophilized, Visual)"
},
"method" : {
"text" : "Visual inspection"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "White to off white cake or powder, essentially free from evidence of contamination with no visible foreign particulates"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:fc07b5d5-9fe1-92c3-2d06-47cb5b295e72",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fc07b5d5-9fe1-92c3-2d06-47cb5b295e72",
"text" : // AppearanceReconstituted
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fc07b5d5-9fe1-92c3-2d06-47cb5b295e72\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fc07b5d5-9fe1-92c3-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72</code></p><p><b>title</b>: Appearance (Reconstituted, Visual)</p><p><b>status</b>: active</p><p><b>code</b>: Appearance (Reconstituted, Visual) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Appearance (Reconstituted, Visual))</span></p><p><b>method</b>: Visual inspection <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72",
"title" : "Appearance (Reconstituted, Visual)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Appearance (Reconstituted, Visual)",
"display" : "Appearance (Reconstituted, Visual)"
}
],
"text" : "Appearance (Reconstituted, Visual)"
},
"method" : {
"text" : "Visual inspection"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Clear, colorless to slightly yellow solution, essentially free of visible particulates"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:3b0e878e-4bc9-8864-862f-e28b21233e8d",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "3b0e878e-4bc9-8864-862f-e28b21233e8d",
"text" : // Identification
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"3b0e878e-4bc9-8864-862f-e28b21233e8d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "3b0e878e-4bc9-8864-862f-e28b21233e8d" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>method</b>: ID by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d",
"title" : "Identification",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"method" : {
"text" : "ID by UHPLC"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Consistent with the retention time and UV spectrum of the reference standard"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"text" : // Assay
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"title" : "Assay",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"method" : {
"text" : "Assay by UHPLC"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "95% to 105% of label claim"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:8bdea820-4197-7c7d-0990-7be06bf78aaf",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "8bdea820-4197-7c7d-0990-7be06bf78aaf",
"text" : // Degradation
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"8bdea820-4197-7c7d-0990-7be06bf78aaf\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "8bdea820-4197-7c7d-0990-7be06bf78aaf" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf</code></p><p><b>title</b>: Degradation Products</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>method</b>: Degradation products by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-1.4</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf",
"title" : "Degradation Products",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
]
},
"method" : {
"text" : "Degradation products by UHPLC"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.3,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 3"
}
],
"range" : {
"high" : {
"value" : 0.3,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Individual unspecified degradation products"
}
],
"range" : {
"high" : {
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Total degradation products"
}
],
"range" : {
"high" : {
"value" : 1.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what impurity this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:31e29d22-5fcb-546e-24fd-52a4a4004467",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "31e29d22-5fcb-546e-24fd-52a4a4004467",
"text" : // Water
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"31e29d22-5fcb-546e-24fd-52a4a4004467\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "31e29d22-5fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP <921> <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-1.0</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467",
"title" : "Water Content",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"method" : {
"text" : "USP <921>"
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 1.0,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:32e29d22-5fcb-546e-24fd-52a4a4004467",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "32e29d22-5fcb-546e-24fd-52a4a4004467",
"text" : // LyophilizationWater
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"32e29d22-5fcb-546e-24fd-52a4a4004467\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "32e29d22-5fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP <921> <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-1.2</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467",
"title" : "Water Content",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"method" : {
"text" : "USP <921>"
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 1.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:32e29d22-6fcb-546e-24fd-52a4a4004467",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "32e29d22-6fcb-546e-24fd-52a4a4004467",
"text" : // LyophilizationWaterHomogeneity
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"32e29d22-6fcb-546e-24fd-52a4a4004467\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "32e29d22-6fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Moisture (%) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WWWH "Water Content Homogeneity")</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>-1.5-1.5 % w/w</td></tr></table><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SSE "Statistically significant effects")</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#UCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Homogeneity "Homogeneity demonstrated")</span></p></blockquote></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467",
"title" : "Water Content",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WWWH",
"display" : "Water Content Homogeneity"
}
],
"text" : "Moisture (%)"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq",
"valueString" : "± 1.4 % (w/w)"
}
],
"range" : {
"low" : {
"value" : -1.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"high" : {
"value" : 1.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
],
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SSE",
"display" : "Statistically significant effects"
}
],
"text" : "Do statistically significant effects"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LCL",
"display" : "Lower one-sided 95% confidence limit of Max Difference"
}
],
"text" : "Lower one-sided 95% confidence limit of Max Difference"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "UCL",
"display" : "Upper one-sided 95% confidence limit of Max Difference"
}
],
"text" : "Upper one-sided 95% confidence limit of Max Difference"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Homogeneity",
"display" : "Homogeneity demonstrated"
}
],
"text" : "Was Homogeneity demonstrated?"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:32e29d32-6fcb-546e-24fd-52a4a4004467",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "32e29d32-6fcb-546e-24fd-52a4a4004467",
"text" : // LyophilizationAssayHomogeneity
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"32e29d32-6fcb-546e-24fd-52a4a4004467\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "32e29d32-6fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay by HPLC (% Main Peak) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSH "Assay Content Homogeneity")</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>-2.3-2.3 %</td></tr></table><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SSE "Statistically significant effects")</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#UCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Homogeneity "Homogeneity demonstrated")</span></p></blockquote></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467",
"title" : "Assay",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSH",
"display" : "Assay Content Homogeneity"
}
],
"text" : "Assay by HPLC (% Main Peak)"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq",
"valueString" : "± 2.3%"
}
],
"range" : {
"low" : {
"value" : -2.3,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"high" : {
"value" : 2.3,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
],
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SSE",
"display" : "Statistically significant effects"
}
],
"text" : "Do statistically significant effects"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LCL",
"display" : "Lower one-sided 95% confidence limit of Max Difference"
}
],
"text" : "Lower one-sided 95% confidence limit of Max Difference"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "UCL",
"display" : "Upper one-sided 95% confidence limit of Max Difference"
}
],
"text" : "Upper one-sided 95% confidence limit of Max Difference"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Homogeneity",
"display" : "Homogeneity demonstrated"
}
],
"text" : "Was Homogeneity demonstrated?"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d7",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "ef17cff1-6586-a5a4-9168-2602140548d7",
"text" : // UniformityUSP
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"ef17cff1-6586-a5a4-9168-2602140548d7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "ef17cff1-6586-a5a4-9168-2602140548d7" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7</code></p><p><b>title</b>: Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim)</p><p><b>status</b>: active</p><p><b>code</b>: Uniformity of Dosage Units, Weight Variation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Uniformity of Dosage Units, Weight Variation)</span></p><p><b>method</b>: Weight variation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>97-? %</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7",
"title" : "Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Uniformity of Dosage Units, Weight Variation",
"display" : "Uniformity of Dosage Units, Weight Variation"
}
],
"text" : "Uniformity of Dosage Units, Weight Variation"
},
"method" : {
"text" : "Weight variation"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 97,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d8",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "ef17cff1-6586-a5a4-9168-2602140548d8",
"text" : // UniformityAcceptance
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"ef17cff1-6586-a5a4-9168-2602140548d8\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "ef17cff1-6586-a5a4-9168-2602140548d8" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8</code></p><p><b>title</b>: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)</p><p><b>status</b>: active</p><p><b>code</b>: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV))</span></p><p><b>method</b>: Weight variation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-25</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8",
"title" : "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)",
"display" : "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"
}
],
"text" : "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"
},
"method" : {
"text" : "Weight variation"
},
"qualifiedValue" : [
{
"range" : {
"high" : // what are units of acceptance value?
{
"value" : 25
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fc17b5d6-9fe1-91c2-2d06-47cb5b295e72",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "fc17b5d6-9fe1-91c2-2d06-47cb5b295e72",
"text" : // releasepH
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"fc17b5d6-9fe1-91c2-2d06-47cb5b295e72\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "fc17b5d6-9fe1-91c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72</code></p><p><b>title</b>: pH (reconstituted)</p><p><b>status</b>: active</p><p><b>code</b>: pH (reconstituted) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (reconstituted))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>6.95-7.05 pH</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72",
"title" : "pH (reconstituted)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (reconstituted)",
"display" : "pH (reconstituted)"
}
],
"text" : "pH (reconstituted)"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 6.95,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
},
"high" : {
"value" : 7.05,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:22515a3c-5034-448a-9c19-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "22515a3c-5034-448a-9c19-938ce1958424",
"text" : // conclusion
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"22515a3c-5034-448a-9c19-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "22515a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: Conclusion</p><p><b>status</b>: active</p><p><b>code</b>: Conclusion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#CONC)</span></p></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424",
"title" : "Conclusion",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "CONC",
"display" : "Conclusion"
}
],
"text" : "Conclusion"
}
}
},
{
"fullUrl" : "urn:uuid:64505a3c-5034-448a-9c19-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64505a3c-5034-448a-9c19-938ce1958424",
"text" : // TAMC
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64505a3c-5034-448a-9c19-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64505a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: TAMC [a]</p><p><b>status</b>: active</p><p><b>code</b>: TAMC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#TAMC)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-10</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424",
"title" : "TAMC [a]",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "TAMC",
"display" : "TAMC"
}
],
"text" : "TAMC"
},
"qualifiedValue" : [
{
"range" : {
"high" : // todo UCUM
{
"value" : 10,
"unit" : "CFU/100ml"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:64515a3c-5034-448a-9c19-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64515a3c-5034-448a-9c19-938ce1958424",
"text" : // TYMC
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64515a3c-5034-448a-9c19-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64515a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: TYMC [a]</p><p><b>status</b>: active</p><p><b>code</b>: TAMC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#TAMC)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-10</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424",
"title" : "TYMC [a]",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "TAMC",
"display" : "TAMC"
}
],
"text" : "TAMC"
},
"qualifiedValue" : [
{
"range" : {
"high" : // todo UCUM
{
"value" : 10,
"unit" : "CFU/100ml"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:64515a3c-5134-448a-9c19-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64515a3c-5134-448a-9c19-938ce1958424",
"text" : // FillWeightAverage
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64515a3c-5134-448a-9c19-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64515a3c-5134-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424</code></p><p><b>title</b>: Fill Weight Average</p><p><b>status</b>: active</p><p><b>code</b>: Fill Weight Average <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Fill Weight Average)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424",
"title" : "Fill Weight Average",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Fill Weight Average",
"display" : "Fill Weight Average"
}
]
},
"qualifiedValue" : [
{
"extension" : [
// todo probably want to just not have this, detect that, and show as N/A
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "N/A"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:64525a3c-5134-448a-9c19-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64525a3c-5134-448a-9c19-938ce1958424",
"text" : // FillWeightTarget
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64525a3c-5134-448a-9c19-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64525a3c-5134-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424</code></p><p><b>title</b>: Fill Weight Target</p><p><b>status</b>: active</p><p><b>code</b>: Fill Weight Target (g) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Fill Weight Target (g))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424",
"title" : "Fill Weight Target",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Fill Weight Target (g)",
"display" : "Fill Weight Target (g)"
}
]
},
"qualifiedValue" : [
{
"extension" : [
// todo probably want to just not have this, detect that, and show as N/A
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "N/A"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:64515a3c-5134-448a-9c29-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64515a3c-5134-448a-9c29-938ce1958424",
"text" : // FillWeightAverageFromTarget
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64515a3c-5134-448a-9c29-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64515a3c-5134-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424</code></p><p><b>title</b>: Actual Avg. Weight from Target</p><p><b>status</b>: active</p><p><b>code</b>: Actual Avg. Weight from Target <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Actual Avg. Weight from Target)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>2-2 %</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424",
"title" : "Actual Avg. Weight from Target",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Actual Avg. Weight from Target",
"display" : "Actual Avg. Weight from Target"
}
]
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq",
"valueString" : "± 2% target (%)"
}
],
"range" : {
"low" : {
"value" : 2,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"high" : {
"value" : 2,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:64515a3c-5234-448a-9c29-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64515a3c-5234-448a-9c29-938ce1958424",
"text" : // HoldTimeFiltrationToFilling
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64515a3c-5234-448a-9c29-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64515a3c-5234-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424</code></p><p><b>title</b>: Hold Time (filtration To filling)</p><p><b>status</b>: active</p><p><b>code</b>: Hold Time (filtration To filling) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Hold Time (filtration To filling))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-2.5</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424",
"title" : "Hold Time (filtration To filling)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Hold Time (filtration To filling)",
"display" : "Hold Time (filtration To filling)"
}
]
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 2.5,
"unit" : "hours",
"system" : "http://unitsofmeasure.org",
"code" : "h"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:64515a3c-5334-448a-9c29-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64515a3c-5334-448a-9c29-938ce1958424",
"text" : // HoldTimeFilling
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64515a3c-5334-448a-9c29-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64515a3c-5334-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424</code></p><p><b>title</b>: Hold Time (start filling to end filling)</p><p><b>status</b>: active</p><p><b>code</b>: Hold Time (start filling to end filling) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Hold Time (start filling to end filling))</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-1.25</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424",
"title" : "Hold Time (start filling to end filling)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Hold Time (start filling to end filling)",
"display" : "Hold Time (start filling to end filling)"
}
]
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 1.25,
"unit" : "hours",
"system" : "http://unitsofmeasure.org",
"code" : "h"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:64535a3c-5334-448a-9c29-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64535a3c-5334-448a-9c29-938ce1958424",
"text" : // FilterIntegrity
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64535a3c-5334-448a-9c29-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64535a3c-5334-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424</code></p><p><b>title</b>: Filter Integrity Test</p><p><b>status</b>: active</p><p><b>code</b>: Filter Integrity Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Filter Integrity Test)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>3.5-? psi</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424",
"title" : "Filter Integrity Test",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Filter Integrity Test",
"display" : "Filter Integrity Test"
}
]
},
"qualifiedValue" : [
{
"range" : {
"low" : // out of scope of ucum apparently
{
"value" : 3.5,
"unit" : "psi",
"system" : "http://unitsofmeasure.org",
"code" : "[psi]"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:22525a3c-5034-448a-9c19-938ce1958424",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "22525a3c-5034-448a-9c19-938ce1958424",
"text" : // LyophilizationConclusion
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"22525a3c-5034-448a-9c19-938ce1958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "22525a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: Conclusion</p><p><b>status</b>: active</p><p><b>code</b>: Conclusion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#CONC)</span></p></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424",
"title" : "Conclusion",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "CONC",
"display" : "Conclusion"
}
],
"text" : "Conclusion"
}
}
},
{
"fullUrl" : "urn:uuid:64535a3c-5334-448a-9c29-938ce2958424",
"resource" : // qualifiedValue>
</qualifiedValue
{
"resourceType" : "ObservationDefinition",
"id" : "64535a3c-5334-448a-9c29-938ce2958424",
"text" : // LyophilizerNumber
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64535a3c-5334-448a-9c29-938ce2958424\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "64535a3c-5334-448a-9c29-938ce2958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424</code></p><p><b>title</b>: Lyophilizer Number</p><p><b>status</b>: active</p><p><b>code</b>: Lyophilizer Number <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Lyophilizer Number)</span></p></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424",
"title" : "Lyophilizer Number",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Lyophilizer Number",
"display" : "Lyophilizer Number"
}
]
}
}
},
{
"fullUrl" : "urn:uuid:22e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "22e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"text" : // LyophilizationAssay
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"22e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "22e7e672-40a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>95-105 %</td></tr></table><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Number of Locations <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LOC)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"title" : "Assay",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"method" : {
"text" : "Assay by UHPLC"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq",
"valueString" : "95% to 105% of label claim"
}
],
"range" : {
"low" : {
"value" : 95,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"high" : {
"value" : 105,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says number of locations
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LOC",
"display" : "Number of Locations"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
"resource" : {
"resourceType" : "Medication",
"id" : "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
"meta" : // medication-batch-information-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Medication-batch-information-drug-pq.html\">Medication - Batch Information Drug PQ</a></p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , , , , , , </td><td>33445</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // todo consider change this be the MID?
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100100,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
},
// Organization/organization-drug-pq-ex1
{
"url" : "container",
"extension" : [
{
"url" : "closureSystemDescription",
"valueString" : "100 cc HDPE Bottle 2 g desiccant"
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-batch-designation-local-pq",
"code" : "maximum",
"display" : "Maximum"
}
],
"text" : "Maximum"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq",
"valuePositiveInt" : 3
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq",
"valueReference" : {
"reference" : "Substance/fc078762-81c5-5656-9744-13c7ad1e595b"
}
},
// Substance/substance-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
},
// Organization/organization-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.81,
"unit" : "kg"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq",
"valueQuantity" : {
"value" : 4.91,
"unit" : "kg"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq",
"valueQuantity" : {
"value" : 30,
"unit" : "g"
}
}
],
"lotNumber" : "33445"
}
}
},
// local extensions
{
"fullUrl" : "urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc",
"resource" : {
"resourceType" : "Medication",
"id" : "a9dfda53-734b-045f-7ae4-94a6281d53bc",
"text" : // medication-actual-batch-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"a9dfda53-734b-045f-7ae4-94a6281d53bc\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , , , , , , </td><td>33446</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100050,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C185328",
"display" : "Stability Study"
}
],
"text" : "PPQ / Stability"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
}
},
// Organization/manufacturer
{
"url" : "container",
"extension" : [
{
"url" : "closureSystemDescription",
"valueString" : "100 cc HDPE Bottle 2 g desiccant"
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-batch-designation-local-pq",
"code" : "maximum",
"display" : "Maximum"
}
],
"text" : "Maximum"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq",
"valuePositiveInt" : 4
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq",
"valueReference" : {
"reference" : "Substance/cb31d747-2338-88d5-342c-8e9c097e4dad"
}
},
// Substance/actual-batch-substance-2
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
}
},
// Organization/packaging
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.82,
"unit" : "kg"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq",
"valueQuantity" : {
"value" : 4.92,
"unit" : "kg"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq",
"valueQuantity" : {
"value" : 30,
"unit" : "g"
}
}
],
"lotNumber" : "33446"
}
}
},
// local extensions
{
"fullUrl" : "urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06",
"resource" : {
"resourceType" : "Medication",
"id" : "c6f5fadd-62e6-3a01-93d9-b3b182f67d06",
"text" : // medication-actual-batch-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"c6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , , , , , , </td><td>33447</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100125,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C185328",
"display" : "Stability Study"
}
],
"text" : "PPQ / Stability"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
}
},
// Organization/manufacturer
{
"url" : "container",
"extension" : [
{
"url" : "closureSystemDescription",
"valueString" : "100 cc HDPE Bottle 2 g desiccant"
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-batch-designation-local-pq",
"code" : "maximum",
"display" : "Maximum"
}
],
"text" : "Maximum"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq",
"valuePositiveInt" : 3
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq",
"valueReference" : {
"reference" : "Substance/1551f97b-6f6d-825e-1fb3-44b0b090808c"
}
},
// Substance/actual-batch-substance-3
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
}
},
// Organization/packaging
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.83,
"unit" : "kg"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq",
"valueQuantity" : {
"value" : 4.93,
"unit" : "kg"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq",
"valueQuantity" : {
"value" : 30,
"unit" : "g"
}
}
],
"lotNumber" : "33447"
}
}
},
// local exensions
{
"fullUrl" : "urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a",
"resource" : {
"resourceType" : "Organization",
"id" : "0102bca4-46c1-a6bf-1025-cd403fee710a",
"text" : // manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"0102bca4-46c1-a6bf-1025-cd403fee710a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a" </p></div><p><b>identifier</b>: id:\u00a03010027650</p><p><b>name</b>: AAA Pharmaceutical, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3010027650"
}
],
"name" : "AAA Pharmaceutical, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"681 Main Street"
],
"city" : "Lumberton",
"state" : "New Jersey",
"postalCode" : "08048",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07",
"resource" : {
"resourceType" : "Organization",
"id" : "378fbe5f-5926-3a5c-4c64-5428df877b07",
"text" : // packaging
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b07\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b07" </p></div><p><b>name</b>: MySite</p></div>"
},
"name" : "MySite"
}
},
{
"fullUrl" : "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08",
"resource" : {
"resourceType" : "Organization",
"id" : "378fbe5f-5926-3a5c-4c64-5428df877b08",
"text" : // testing lab
// 378fbe5f-5926-3a5c-4c64-5428df877b08
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b08\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" </p></div><p><b>name</b>: Testing Lab</p></div>"
},
"name" : "Testing Lab"
}
},
{
"fullUrl" : "urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd",
"resource" : {
"resourceType" : "DiagnosticReport",
"id" : "processValidationReport",
"text" : // ideally this wants a subject, but it can only be a Medication (batch) and we have multiple.
however the observations themselves do have subjects
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DiagnosticReport</b><a name=\"processValidationReport\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource DiagnosticReport "processValidationReport" </p></div><p><b>Triggered by</b>: <a href=\"#PlanDefinition_2038e4c7-22b8-4c56-2d28-6c077648763f\">See above (PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Process Validation Report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-reportType-local-pq.html\">CodeSystem - Report Type</a>#Process Validation Report)</span></p><p><b>effective</b>: 2020-12</p><p><b>result</b>: </p><ul><li><a href=\"#Observation_9c56948a-2a39-6609-1c01-4d197ea57a33\">See above (Observation/9c56948a-2a39-6609-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-3a39-6609-1c01-4d197ea57a33\">See above (Observation/9c56948a-3a39-6609-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-4a39-6609-1c01-4d197ea57a33\">See above (Observation/9c56948a-4a39-6609-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-3a49-6609-1c01-4d197ea57a33\">See above (Observation/9c56948a-3a49-6609-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56958a-4a39-6609-1c01-4d197ea57a33\">See above (Observation/9c56958a-4a39-6609-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-5a39-6609-1c01-4d197ea57a33\">See above (Observation/9c56948a-5a39-6609-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-2a39-6609-1c01-4d297ea57a33\">See above (Observation/9c56948a-2a39-6609-1c01-4d297ea57a33)</a></li><li><a href=\"#Observation_9c56948a-3a39-6619-1c01-4d197ea57a33\">See above (Observation/9c56948a-3a39-6619-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-4a39-6619-1c01-4d197ea57a33\">See above (Observation/9c56948a-4a39-6619-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-3a49-6619-1c01-4d197ea57a33\">See above (Observation/9c56948a-3a49-6619-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56958a-4a39-6619-1c01-4d197ea57a33\">See above (Observation/9c56958a-4a39-6619-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_9c56948a-5a39-6709-1c01-4d197ea57a33\">See above (Observation/9c56948a-5a39-6709-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_f0a04328-905c-4ec5-372e-4d6cfef18629\">See above (Observation/f0a04328-905c-4ec5-372e-4d6cfef18629)</a></li><li><a href=\"#Observation_5e5a5e67-7fc6-0064-1be9-5d9d14d887e5\">See above (Observation/5e5a5e67-7fc6-0064-1be9-5d9d14d887e5)</a></li><li><a href=\"#Observation_cfde6776-673c-72e2-68c4-07b77cd85b74\">See above (Observation/cfde6776-673c-72e2-68c4-07b77cd85b74)</a></li><li><a href=\"#Observation_9c56948a-1a39-6609-1c01-4d197ea57a33\">See above (Observation/9c56948a-1a39-6609-1c01-4d197ea57a33)</a></li><li><a href=\"#Observation_1e20aed7-7626-1664-8d96-235f860d9a2c\">See above (Observation/1e20aed7-7626-1664-8d96-235f860d9a2c)</a></li><li><a href=\"#Observation_ec6d7e30-4d70-491b-0669-a613eedd3c60\">See above (Observation/ec6d7e30-4d70-491b-0669-a613eedd3c60)</a></li><li><a href=\"#Observation_ab7997fa-7b46-1175-3f01-6f6997f7878a\">See above (Observation/ab7997fa-7b46-1175-3f01-6f6997f7878a)</a></li><li><a href=\"#Observation_4052f28b-64a2-392d-35e4-ec8e912434d2\">See above (Observation/4052f28b-64a2-392d-35e4-ec8e912434d2)</a></li><li><a href=\"#Observation_34ebc51d-8105-0589-3c8d-e7aa6bd0a06c\">See above (Observation/34ebc51d-8105-0589-3c8d-e7aa6bd0a06c)</a></li><li><a href=\"#Observation_2940bf11-05bf-6ce2-3c64-457d0d1f9913\">See above (Observation/2940bf11-05bf-6ce2-3c64-457d0d1f9913)</a></li><li><a href=\"#Observation_332b1e76-6f70-2b4e-5d0c-f22a0e042d3e\">See above (Observation/332b1e76-6f70-2b4e-5d0c-f22a0e042d3e)</a></li><li><a href=\"#Observation_f0a13a3b-2e8b-594f-6874-6050511e4c57\">See above (Observation/f0a13a3b-2e8b-594f-6874-6050511e4c57)</a></li><li><a href=\"#Observation_7fe7ccd7-6449-0186-2282-3eeb4cf6a795\">See above (Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a795)</a></li><li><a href=\"#Observation_be016630-8754-7414-9014-21e020ad66c6\">See above (Observation/be016630-8754-7414-9014-21e020ad66c6)</a></li><li><a href=\"#Observation_92568f68-78f3-908c-6935-ff5f3d574dd6\">See above (Observation/92568f68-78f3-908c-6935-ff5f3d574dd6)</a></li><li><a href=\"#Observation_a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12\">See above (Observation/a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12)</a></li><li><a href=\"#Observation_d8533dcb-03f8-5997-6ccf-4f9b6f7a5745\">See above (Observation/d8533dcb-03f8-5997-6ccf-4f9b6f7a5745)</a></li><li><a href=\"#Observation_7cec19a2-34a7-6b80-3d60-083b2cc64fcb\">See above (Observation/7cec19a2-34a7-6b80-3d60-083b2cc64fcb)</a></li><li><a href=\"#Observation_27aa47fd-7964-4f96-6495-b2bec7f160e7\">See above (Observation/27aa47fd-7964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_6a78bcde-4781-226c-946e-a4b6915c1899\">See above (Observation/6a78bcde-4781-226c-946e-a4b6915c1899)</a></li><li><a href=\"#Observation_f9f11088-7527-947c-3d3f-e71b32e13c78\">See above (Observation/f9f11088-7527-947c-3d3f-e71b32e13c78)</a></li><li><a href=\"#Observation_66c2f585-678e-78b8-2235-1a3b37bd6e46\">See above (Observation/66c2f585-678e-78b8-2235-1a3b37bd6e46)</a></li><li><a href=\"#Observation_f8232d25-023d-679f-9c58-a6dc234b7a28\">See above (Observation/f8232d25-023d-679f-9c58-a6dc234b7a28)</a></li><li><a href=\"#Observation_368b82be-75dd-1d97-3dbc-a7eed9869daa\">See above (Observation/368b82be-75dd-1d97-3dbc-a7eed9869daa)</a></li><li><a href=\"#Observation_44aa47fd-8964-4f96-6495-b2bec7f160e7\">See above (Observation/44aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_45aa47fd-8964-4f96-6495-b2bec7f160e7\">See above (Observation/45aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_45ab47fd-8964-4f96-6495-b2bec7f160e7\">See above (Observation/45ab47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_37aa47fd-8964-4f96-6495-b2bec7f160e7\">See above (Observation/37aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_38aa47fd-8964-4f96-6495-b2bec7f160e7\">See above (Observation/38aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_38aa48fd-8964-4f96-6495-b2bec7f160e7\">See above (Observation/38aa48fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_37aa47fd-7964-4f96-6495-b2bec7f160e7\">See above (Observation/37aa47fd-7964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_47aa47fd-7964-4f96-6495-b2bec7f160e7\">See above (Observation/47aa47fd-7964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_47aa47fd-7964-4f96-6495-b2bec7f160e8\">See above (Observation/47aa47fd-7964-4f96-6495-b2bec7f160e8)</a></li><li><a href=\"#Observation_47aa47fd-8964-4f96-6495-b2bec7f160e7\">See above (Observation/47aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href=\"#Observation_47aa47fd-8964-5f96-6495-b2bec7f160e7\">See above (Observation/47aa47fd-8964-5f96-6495-b2bec7f160e7)</a></li></ul><p><b>conclusion</b>: The samples have been assessed and the conclusion is...</p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f"
}
}
],
"status" : "final",
"code" : // PlanDefinition/validationProtocol
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq",
"code" : "Process Validation Report",
"display" : "Process Validation Report"
}
]
},
"effectiveDateTime" : "2020-12",
"result" : [
{
"reference" : "Observation/9c56948a-2a39-6609-1c01-4d197ea57a33"
},
// Observation/compoundingpHPre1
{
"reference" : "Observation/9c56948a-3a39-6609-1c01-4d197ea57a33"
},
// Observation/compoundingpHPre2
{
"reference" : "Observation/9c56948a-4a39-6609-1c01-4d197ea57a33"
},
// Observation/compoundingpHPre3
{
"reference" : "Observation/9c56948a-3a49-6609-1c01-4d197ea57a33"
},
// Observation/compoundingpHPost1
{
"reference" : "Observation/9c56958a-4a39-6609-1c01-4d197ea57a33"
},
// Observation/compoundingpHPost2
{
"reference" : "Observation/9c56948a-5a39-6609-1c01-4d197ea57a33"
},
// Observation/compoundingpHPost3
{
"reference" : "Observation/9c56948a-2a39-6609-1c01-4d297ea57a33"
},
// Observation/compoundingAssayPre1
{
"reference" : "Observation/9c56948a-3a39-6619-1c01-4d197ea57a33"
},
// Observation/compoundingAssayPre2
{
"reference" : "Observation/9c56948a-4a39-6619-1c01-4d197ea57a33"
},
// Observation/compoundingAssayPre3
{
"reference" : "Observation/9c56948a-3a49-6619-1c01-4d197ea57a33"
},
// Observation/compoundingAssayPost1
{
"reference" : "Observation/9c56958a-4a39-6619-1c01-4d197ea57a33"
},
// Observation/compoundingAssayPost2
{
"reference" : "Observation/9c56948a-5a39-6709-1c01-4d197ea57a33"
},
// Observation/compoundingAssayPost3
{
"reference" : "Observation/f0a04328-905c-4ec5-372e-4d6cfef18629"
},
// Observation/observationIdentification
{
"reference" : "Observation/5e5a5e67-7fc6-0064-1be9-5d9d14d887e5"
},
// Observation/observationIdentification2
{
"reference" : "Observation/cfde6776-673c-72e2-68c4-07b77cd85b74"
},
// Observation/observationIdentification3
{
"reference" : "Observation/9c56948a-1a39-6609-1c01-4d197ea57a33"
},
// Observation/observationAssay
{
"reference" : "Observation/1e20aed7-7626-1664-8d96-235f860d9a2c"
},
// Observation/observationAssay2
{
"reference" : "Observation/ec6d7e30-4d70-491b-0669-a613eedd3c60"
},
// Observation/observationAssay3
{
"reference" : "Observation/ab7997fa-7b46-1175-3f01-6f6997f7878a"
},
// Observation/observationDegradation-imp1
{
"reference" : "Observation/4052f28b-64a2-392d-35e4-ec8e912434d2"
},
// Observation/observationDegradation-imp1-2
{
"reference" : "Observation/34ebc51d-8105-0589-3c8d-e7aa6bd0a06c"
},
// Observation/observationDegradation-imp1-3
{
"reference" : "Observation/2940bf11-05bf-6ce2-3c64-457d0d1f9913"
},
// Observation/observationDegradation-imp2
{
"reference" : "Observation/332b1e76-6f70-2b4e-5d0c-f22a0e042d3e"
},
// Observation/observationDegradation-imp2-2
{
"reference" : "Observation/f0a13a3b-2e8b-594f-6874-6050511e4c57"
},
// Observation/observationDegradation-imp2-3
{
"reference" : "Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a795"
},
// Observation/observationDegradation-imp3
{
"reference" : "Observation/be016630-8754-7414-9014-21e020ad66c6"
},
// Observation/observationDegradation-imp3-2
{
"reference" : "Observation/92568f68-78f3-908c-6935-ff5f3d574dd6"
},
// Observation/observationDegradation-imp3-3
{
"reference" : "Observation/a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12"
},
// Observation/observationDegradation-imp-unspecified
{
"reference" : "Observation/d8533dcb-03f8-5997-6ccf-4f9b6f7a5745"
},
// Observation/observationDegradation-imp-unspecified-2
{
"reference" : "Observation/7cec19a2-34a7-6b80-3d60-083b2cc64fcb"
},
// Observation/observationDegradation-imp-unspecified-3
{
"reference" : "Observation/27aa47fd-7964-4f96-6495-b2bec7f160e7"
},
// Observation/observationDegradation-imp-total
{
"reference" : "Observation/6a78bcde-4781-226c-946e-a4b6915c1899"
},
// Observation/observationDegradation-imp-total-2
{
"reference" : "Observation/f9f11088-7527-947c-3d3f-e71b32e13c78"
},
// Observation/observationDegradation-imp-total-3
{
"reference" : "Observation/66c2f585-678e-78b8-2235-1a3b37bd6e46"
},
// Observation/observationWater
{
"reference" : "Observation/f8232d25-023d-679f-9c58-a6dc234b7a28"
},
// Observation/observationWater2
{
"reference" : "Observation/368b82be-75dd-1d97-3dbc-a7eed9869daa"
},
// Observation/observationWater3
{
"reference" : "Observation/44aa47fd-8964-4f96-6495-b2bec7f160e7"
},
// Observation/fillingTAMC1
{
"reference" : "Observation/45aa47fd-8964-4f96-6495-b2bec7f160e7"
},
// Observation/fillingConclusion-nosubject
{
"reference" : "Observation/45ab47fd-8964-4f96-6495-b2bec7f160e7"
},
// Observation/lyophilizationConclusion-nosubject
{
"reference" : "Observation/37aa47fd-8964-4f96-6495-b2bec7f160e7"
},
// Observation/lyophilizerNumber1
{
"reference" : "Observation/38aa47fd-8964-4f96-6495-b2bec7f160e7"
},
// Observation/lyophilizerNumber2
{
"reference" : "Observation/38aa48fd-8964-4f96-6495-b2bec7f160e7"
},
// Observation/lyophilizerNumber3
{
"reference" : "Observation/37aa47fd-7964-4f96-6495-b2bec7f160e7"
},
// Observation/lyophilizationAssay1
{
"reference" : "Observation/47aa47fd-7964-4f96-6495-b2bec7f160e7"
},
// Observation/lyophilizationAssay2
{
"reference" : "Observation/47aa47fd-7964-4f96-6495-b2bec7f160e8"
},
// Observation/lyophilizationAssay3
{
"reference" : "Observation/47aa47fd-8964-4f96-6495-b2bec7f160e7"
},
// Observation/lyophilizerWaterHomogeneity1
{
"reference" : "Observation/47aa47fd-8964-5f96-6495-b2bec7f160e7"
}
],
"conclusion" : "The samples have been assessed and the conclusion is..."
}
},
// Observation/lyophilizerAssayHomogeneity1
{
"fullUrl" : "urn:uuid:f0a04328-905c-4ec5-372e-4d6cfef18629",
"resource" : {
"resourceType" : "Observation",
"id" : "f0a04328-905c-4ec5-372e-4d6cfef18629",
"text" : // observationIdentification
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f0a04328-905c-4ec5-372e-4d6cfef18629\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f0a04328-905c-4ec5-372e-4d6cfef18629" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_3b0e878e-4bc9-8864-862f-e28b21233e8d\">See above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
},
{
"fullUrl" : "urn:uuid:5e5a5e67-7fc6-0064-1be9-5d9d14d887e5",
"resource" : {
"resourceType" : "Observation",
"id" : "5e5a5e67-7fc6-0064-1be9-5d9d14d887e5",
"text" : // observationIdentification2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"5e5a5e67-7fc6-0064-1be9-5d9d14d887e5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "5e5a5e67-7fc6-0064-1be9-5d9d14d887e5" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_3b0e878e-4bc9-8864-862f-e28b21233e8d\">See above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Does not comply <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Does not comply"
}
}
},
{
"fullUrl" : "urn:uuid:cfde6776-673c-72e2-68c4-07b77cd85b74",
"resource" : {
"resourceType" : "Observation",
"id" : "cfde6776-673c-72e2-68c4-07b77cd85b74",
"text" : // observationIdentification3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"cfde6776-673c-72e2-68c4-07b77cd85b74\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "cfde6776-673c-72e2-68c4-07b77cd85b74" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_3b0e878e-4bc9-8864-862f-e28b21233e8d\">See above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-2a39-6609-1c01-4d197ea57a33",
"text" : // compoundingpHPre1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-2a39-6609-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-2a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e72\">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.91 pH<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code pH = 'pH')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingpHPre
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (adjustment of pre-clarification bulk solution)",
"display" : "pH (adjustment of pre-clarification bulk solution)"
}
],
"text" : "pH (adjustment of pre-clarification bulk solution)"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 6.91,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-3a39-6609-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-3a39-6609-1c01-4d197ea57a33",
"text" : // compoundingpHPre2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-3a39-6609-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-3a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e72\">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.92 pH<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code pH = 'pH')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingpHPre
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (adjustment of pre-clarification bulk solution)",
"display" : "pH (adjustment of pre-clarification bulk solution)"
}
],
"text" : "pH (adjustment of pre-clarification bulk solution)"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 6.92,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-4a39-6609-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-4a39-6609-1c01-4d197ea57a33",
"text" : // compoundingpHPre3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-4a39-6609-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-4a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e72\">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.93 pH<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code pH = 'pH')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingpHPre
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (adjustment of pre-clarification bulk solution)",
"display" : "pH (adjustment of pre-clarification bulk solution)"
}
],
"text" : "pH (adjustment of pre-clarification bulk solution)"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 6.93,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-3a49-6609-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-3a49-6609-1c01-4d197ea57a33",
"text" : // compoundingpHPost1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-3a49-6609-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-3a49-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e73\">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 7.01 pH<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code pH = 'pH')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingpHPost
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (adjustment of pre-clarification bulk solution)",
"display" : "pH (adjustment of pre-clarification bulk solution)"
}
],
"text" : "pH (adjustment of pre-clarification bulk solution)"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 7.01,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
},
{
"fullUrl" : "urn:uuid:9c56958a-4a39-6609-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56958a-4a39-6609-1c01-4d197ea57a33",
"text" : // compoundingpHPost2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56958a-4a39-6609-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56958a-4a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e73\">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 7.02 pH<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code pH = 'pH')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingpHPost
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (adjustment of pre-clarification bulk solution)",
"display" : "pH (adjustment of pre-clarification bulk solution)"
}
],
"text" : "pH (adjustment of pre-clarification bulk solution)"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 7.02,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-5a39-6609-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-5a39-6609-1c01-4d197ea57a33",
"text" : // compoundingpHPost3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-5a39-6609-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-5a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e73\">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.93 pH<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code pH = 'pH')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingpHPost
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH (adjustment of pre-clarification bulk solution)",
"display" : "pH (adjustment of pre-clarification bulk solution)"
}
],
"text" : "pH (adjustment of pre-clarification bulk solution)"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 6.93,
"unit" : "pH",
"system" : "http://unitsofmeasure.org",
"code" : "pH"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-2a39-6609-1c01-4d297ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-2a39-6609-1c01-4d297ea57a33",
"text" : // compoundingAssayPre1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-2a39-6609-1c01-4d297ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-2a39-6609-1c01-4d297ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e72\">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (pre-clarification filtration) (mg/mL))</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 21.1 mg/mL<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingAssayPre
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (pre-clarification filtration) (mg/mL)",
"display" : "Assay (pre-clarification filtration) (mg/mL)"
}
],
"text" : "Assay (pre-clarification filtration) (mg/mL)"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 21.1,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-3a39-6619-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-3a39-6619-1c01-4d197ea57a33",
"text" : // compoundingAssayPre2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-3a39-6619-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-3a39-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e72\">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (pre-clarification filtration) (mg/mL))</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 21.2 mg/mL<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingAssayPre
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (pre-clarification filtration) (mg/mL)",
"display" : "Assay (pre-clarification filtration) (mg/mL)"
}
],
"text" : "Assay (pre-clarification filtration) (mg/mL)"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 21.2,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-4a39-6619-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-4a39-6619-1c01-4d197ea57a33",
"text" : // compoundingAssayPre3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-4a39-6619-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-4a39-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e72\">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (pre-clarification filtration) (mg/mL))</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 21.3 mg/mL<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingAssayPre
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (pre-clarification filtration) (mg/mL)",
"display" : "Assay (pre-clarification filtration) (mg/mL)"
}
],
"text" : "Assay (pre-clarification filtration) (mg/mL)"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 21.3,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-3a49-6619-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-3a49-6619-1c01-4d197ea57a33",
"text" : // compoundingAssayPost1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-3a49-6619-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-3a49-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e73\">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (Post dilution bulk solution) (mg/mL))</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 20.1 mg/mL<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingAssayPost
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (Post dilution bulk solution) (mg/mL)",
"display" : "Assay (Post dilution bulk solution) (mg/mL)"
}
],
"text" : "Assay (Post dilution bulk solution) (mg/mL)"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 20.1,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
},
{
"fullUrl" : "urn:uuid:9c56958a-4a39-6619-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56958a-4a39-6619-1c01-4d197ea57a33",
"text" : // compoundingAssayPost2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56958a-4a39-6619-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56958a-4a39-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e73\">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (Post dilution bulk solution) (mg/mL))</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 20.2 mg/mL<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingAssayPost
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (Post dilution bulk solution) (mg/mL)",
"display" : "Assay (Post dilution bulk solution) (mg/mL)"
}
],
"text" : "Assay (Post dilution bulk solution) (mg/mL)"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 20.2,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-5a39-6709-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-5a39-6709-1c01-4d197ea57a33",
"text" : // compoundingAssayPost3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-5a39-6709-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-5a39-6709-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e73\">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Assay (Post dilution bulk solution) (mg/mL))</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 20.3 mg/mL<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"
},
"status" : "final",
"code" : // ObservationDefinition/compoundingAssayPost
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Assay (Post dilution bulk solution) (mg/mL)",
"display" : "Assay (Post dilution bulk solution) (mg/mL)"
}
],
"text" : "Assay (Post dilution bulk solution) (mg/mL)"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 20.3,
"unit" : "mg/mL",
"system" : "http://unitsofmeasure.org",
"code" : "mg/mL"
}
}
},
{
"fullUrl" : "urn:uuid:9c56948a-1a39-6609-1c01-4d197ea57a33",
"resource" : {
"resourceType" : "Observation",
"id" : "9c56948a-1a39-6609-1c01-4d197ea57a33",
"text" : // observationAssay
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c56948a-1a39-6609-1c01-4d197ea57a33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c56948a-1a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 103 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 103,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:1e20aed7-7626-1664-8d96-235f860d9a2c",
"resource" : {
"resourceType" : "Observation",
"id" : "1e20aed7-7626-1664-8d96-235f860d9a2c",
"text" : // observationAssay2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"1e20aed7-7626-1664-8d96-235f860d9a2c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "1e20aed7-7626-1664-8d96-235f860d9a2c" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 102 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 102,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:ec6d7e30-4d70-491b-0669-a613eedd3c60",
"resource" : {
"resourceType" : "Observation",
"id" : "ec6d7e30-4d70-491b-0669-a613eedd3c60",
"text" : // observationAssay3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"ec6d7e30-4d70-491b-0669-a613eedd3c60\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "ec6d7e30-4d70-491b-0669-a613eedd3c60" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 101 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 101,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:ab7997fa-7b46-1175-3f01-6f6997f7878a",
"resource" : {
"resourceType" : "Observation",
"id" : "ab7997fa-7b46-1175-3f01-6f6997f7878a",
"text" : // observationDegradation-imp1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"ab7997fa-7b46-1175-3f01-6f6997f7878a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "ab7997fa-7b46-1175-3f01-6f6997f7878a" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:4052f28b-64a2-392d-35e4-ec8e912434d2",
"resource" : {
"resourceType" : "Observation",
"id" : "4052f28b-64a2-392d-35e4-ec8e912434d2",
"text" : // observationDegradation-imp1-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"4052f28b-64a2-392d-35e4-ec8e912434d2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "4052f28b-64a2-392d-35e4-ec8e912434d2" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:34ebc51d-8105-0589-3c8d-e7aa6bd0a06c",
"resource" : {
"resourceType" : "Observation",
"id" : "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c",
"text" : // observationDegradation-imp1-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"34ebc51d-8105-0589-3c8d-e7aa6bd0a06c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:2940bf11-05bf-6ce2-3c64-457d0d1f9913",
"resource" : {
"resourceType" : "Observation",
"id" : "2940bf11-05bf-6ce2-3c64-457d0d1f9913",
"text" : // observationDegradation-imp2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"2940bf11-05bf-6ce2-3c64-457d0d1f9913\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "2940bf11-05bf-6ce2-3c64-457d0d1f9913" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:332b1e76-6f70-2b4e-5d0c-f22a0e042d3e",
"resource" : {
"resourceType" : "Observation",
"id" : "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e",
"text" : // observationDegradation-imp2-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"332b1e76-6f70-2b4e-5d0c-f22a0e042d3e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:f0a13a3b-2e8b-594f-6874-6050511e4c57",
"resource" : {
"resourceType" : "Observation",
"id" : "f0a13a3b-2e8b-594f-6874-6050511e4c57",
"text" : // observationDegradation-imp2-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f0a13a3b-2e8b-594f-6874-6050511e4c57\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f0a13a3b-2e8b-594f-6874-6050511e4c57" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:7fe7ccd7-6449-0186-2282-3eeb4cf6a795",
"resource" : {
"resourceType" : "Observation",
"id" : "7fe7ccd7-6449-0186-2282-3eeb4cf6a795",
"text" : // observationDegradation-imp3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"7fe7ccd7-6449-0186-2282-3eeb4cf6a795\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a795" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:be016630-8754-7414-9014-21e020ad66c6",
"resource" : {
"resourceType" : "Observation",
"id" : "be016630-8754-7414-9014-21e020ad66c6",
"text" : // observationDegradation-imp3-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"be016630-8754-7414-9014-21e020ad66c6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "be016630-8754-7414-9014-21e020ad66c6" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:92568f68-78f3-908c-6935-ff5f3d574dd6",
"resource" : {
"resourceType" : "Observation",
"id" : "92568f68-78f3-908c-6935-ff5f3d574dd6",
"text" : // observationDegradation-imp3-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"92568f68-78f3-908c-6935-ff5f3d574dd6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd6" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12",
"resource" : {
"resourceType" : "Observation",
"id" : "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12",
"text" : // observationDegradation-imp-unspecified
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Individual unspecified degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Individual unspecified degradation products"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:d8533dcb-03f8-5997-6ccf-4f9b6f7a5745",
"resource" : {
"resourceType" : "Observation",
"id" : "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745",
"text" : // observationDegradation-imp-unspecified-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"d8533dcb-03f8-5997-6ccf-4f9b6f7a5745\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Individual unspecified degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Individual unspecified degradation products"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:7cec19a2-34a7-6b80-3d60-083b2cc64fcb",
"resource" : {
"resourceType" : "Observation",
"id" : "7cec19a2-34a7-6b80-3d60-083b2cc64fcb",
"text" : // observationDegradation-imp-unspecified-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"7cec19a2-34a7-6b80-3d60-083b2cc64fcb\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "7cec19a2-34a7-6b80-3d60-083b2cc64fcb" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Individual unspecified degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Individual unspecified degradation products"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "27aa47fd-7964-4f96-6495-b2bec7f160e7",
"text" : // observationDegradation-imp-total
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"27aa47fd-7964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.6 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.6,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total degradation products"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:6a78bcde-4781-226c-946e-a4b6915c1899",
"resource" : {
"resourceType" : "Observation",
"id" : "6a78bcde-4781-226c-946e-a4b6915c1899",
"text" : // observationDegradation-imp-total-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"6a78bcde-4781-226c-946e-a4b6915c1899\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1899" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.7 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.7,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total degradation products"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c78",
"resource" : {
"resourceType" : "Observation",
"id" : "f9f11088-7527-947c-3d3f-e71b32e13c78",
"text" : // observationDegradation-imp-total-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f9f11088-7527-947c-3d3f-e71b32e13c78\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c78" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf\">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.6 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.6,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total degradation products"
}
}
]
}
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:66c2f585-678e-78b8-2235-1a3b37bd6e46",
"resource" : {
"resourceType" : "Observation",
"id" : "66c2f585-678e-78b8-2235-1a3b37bd6e46",
"text" : // observationWater
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"66c2f585-678e-78b8-2235-1a3b37bd6e46\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "66c2f585-678e-78b8-2235-1a3b37bd6e46" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_31e29d22-5fcb-546e-24fd-52a4a4004467\">See above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:f8232d25-023d-679f-9c58-a6dc234b7a28",
"resource" : {
"resourceType" : "Observation",
"id" : "f8232d25-023d-679f-9c58-a6dc234b7a28",
"text" : // observationWater2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f8232d25-023d-679f-9c58-a6dc234b7a28\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f8232d25-023d-679f-9c58-a6dc234b7a28" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_31e29d22-5fcb-546e-24fd-52a4a4004467\">See above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:368b82be-75dd-1d97-3dbc-a7eed9869daa",
"resource" : {
"resourceType" : "Observation",
"id" : "368b82be-75dd-1d97-3dbc-a7eed9869daa",
"text" : // observationWater3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"368b82be-75dd-1d97-3dbc-a7eed9869daa\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "368b82be-75dd-1d97-3dbc-a7eed9869daa" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_31e29d22-5fcb-546e-24fd-52a4a4004467\">See above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "44aa47fd-8964-4f96-6495-b2bec7f160e7",
"text" : // fillingTAMC1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"44aa47fd-8964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "44aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_64505a3c-5034-448a-9c19-938ce1958424\">See above (ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: TAMC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#TAMC)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 9.1 CFU/100ml</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424"
},
"status" : "final",
"code" : // ObservationDefinition/TAMC
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "TAMC",
"display" : "TAMC"
}
],
"text" : "TAMC"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
// todo UCUM
{
"value" : 9.1,
"unit" : "CFU/100ml"
}
}
},
{
"fullUrl" : "urn:uuid:45aa47fd-8964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "45aa47fd-8964-4f96-6495-b2bec7f160e7",
"text" : // fillingConclusion-nosubject
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"45aa47fd-8964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "45aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_22515a3c-5034-448a-9c19-938ce1958424\">See above (ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Conclusion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#CONC)</span></p><p><b>subject</b>: <span>: all batches</span></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Conclusion of filling tests....</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"
},
"status" : "final",
"code" : // ObservationDefinition/conclusion
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "CONC",
"display" : "Conclusion"
}
],
"text" : "Conclusion"
},
"subject" : // no subject because it applies to all the samples
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
"valueCode" : "unsupported"
}
],
"display" : "all batches"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueString" : "Conclusion of filling tests...."
}
},
// Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"fullUrl" : "urn:uuid:45ab47fd-8964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "45ab47fd-8964-4f96-6495-b2bec7f160e7",
"text" : // no subject
// lyophilizationConclusion-nosubject
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"45ab47fd-8964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "45ab47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_22525a3c-5034-448a-9c19-938ce1958424\">See above (ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Conclusion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#CONC)</span></p><p><b>subject</b>: <span>: all batches</span></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Conclusion of lyophilization tests....</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizationConclusion
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "CONC",
"display" : "Conclusion"
}
],
"text" : "Conclusion"
},
"subject" : // no subject because it applies to all the samples
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
"valueCode" : "unsupported"
}
],
"display" : "all batches"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueString" : "Conclusion of lyophilization tests...."
}
},
// Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"fullUrl" : "urn:uuid:37aa47fd-8964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "37aa47fd-8964-4f96-6495-b2bec7f160e7",
"text" : // lyophilizerNumber1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"37aa47fd-8964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "37aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_64535a3c-5334-448a-9c29-938ce2958424\">See above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Lyophilizer Number "Lyophilizer Number")</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1234</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizerNumber
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Lyophilizer Number",
"display" : "Lyophilizer Number"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 1234
}
}
},
{
"fullUrl" : "urn:uuid:38aa47fd-8964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "38aa47fd-8964-4f96-6495-b2bec7f160e7",
"text" : // lyophilizerNumber2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"38aa47fd-8964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "38aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_64535a3c-5334-448a-9c29-938ce2958424\">See above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Lyophilizer Number "Lyophilizer Number")</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1235</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizerNumber
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Lyophilizer Number",
"display" : "Lyophilizer Number"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 1235
}
}
},
{
"fullUrl" : "urn:uuid:38aa48fd-8964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "38aa48fd-8964-4f96-6495-b2bec7f160e7",
"text" : // lyophilizerNumber3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"38aa48fd-8964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "38aa48fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_64535a3c-5334-448a-9c29-938ce2958424\">See above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Lyophilizer Number "Lyophilizer Number")</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1236</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizerNumber
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Lyophilizer Number",
"display" : "Lyophilizer Number"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 1236
}
}
},
{
"fullUrl" : "urn:uuid:37aa47fd-7964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "37aa47fd-7964-4f96-6495-b2bec7f160e7",
"text" : // lyophilizationAssay1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"37aa47fd-7964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "37aa47fd-7964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_22e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 97 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Number of Locations <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LOC)</span></td><td>3</td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizationAssay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 97,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LOC",
"display" : "Number of Locations"
}
]
},
"valueInteger" : 3
}
]
}
},
{
"fullUrl" : "urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "47aa47fd-7964-4f96-6495-b2bec7f160e7",
"text" : // lyophilizationAssay2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"47aa47fd-7964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "47aa47fd-7964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_22e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 98 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Number of Locations <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LOC)</span></td><td>4</td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizationAssay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 98,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LOC",
"display" : "Number of Locations"
}
]
},
"valueInteger" : 4
}
]
}
},
{
"fullUrl" : "urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e8",
"resource" : {
"resourceType" : "Observation",
"id" : "47aa47fd-7964-4f96-6495-b2bec7f160e8",
"text" : // lyophilizationAssay3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"47aa47fd-7964-4f96-6495-b2bec7f160e8\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "47aa47fd-7964-4f96-6495-b2bec7f160e8" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_22e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 96 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Number of Locations <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LOC)</span></td><td>2</td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizationAssay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 96,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LOC",
"display" : "Number of Locations"
}
]
},
"valueInteger" : 2
}
]
}
},
{
"fullUrl" : "urn:uuid:47aa47fd-8964-4f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "47aa47fd-8964-4f96-6495-b2bec7f160e7",
"text" : // lyophilizerWaterHomogeneity1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"47aa47fd-8964-4f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "47aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_32e29d22-6fcb-546e-24fd-52a4a4004467\">See above (ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467)</a></p><p><b>status</b>: final</p><p><b>code</b>: Lyophilization Water Homogeneity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Lyophilization Water Homogeneity)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SSE "Statistically significant effects")</span></p><p><b>value</b>: Yes</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LCL)</span></p><p><b>value</b>: 0.8 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#UCL)</span></p><p><b>value</b>: 0.9 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Homogeneity "Homogeneity demonstrated")</span></p><p><b>value</b>: Yes</p></blockquote></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizationWaterHomogeneity
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Lyophilization Water Homogeneity",
"display" : "Lyophilization Water Homogeneity"
}
],
"text" : "Lyophilization Water Homogeneity"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"component" : [
// Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SSE",
"display" : "Statistically significant effects"
}
],
"text" : "Do statistically significant effects"
},
"valueString" : "Yes"
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LCL",
"display" : "Lower one-sided 95% confidence limit of Max Difference"
}
]
},
"valueQuantity" : {
"value" : 0.8,
"unit" : "%"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "UCL",
"display" : "Upper one-sided 95% confidence limit of Max Difference"
}
],
"text" : "Upper one-sided 95% confidence limit of Max Difference"
},
"valueQuantity" : {
"value" : 0.9,
"unit" : "%"
}
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Homogeneity",
"display" : "Homogeneity demonstrated"
}
],
"text" : "Was Homogeneity demonstrated?"
},
"valueString" : "Yes"
}
]
}
},
// boolean?
{
"fullUrl" : "urn:uuid:47aa47fd-8964-5f96-6495-b2bec7f160e7",
"resource" : {
"resourceType" : "Observation",
"id" : "47aa47fd-8964-5f96-6495-b2bec7f160e7",
"text" : // lyophilizerAssayHomogeneity1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"47aa47fd-8964-5f96-6495-b2bec7f160e7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "47aa47fd-8964-5f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_32e29d32-6fcb-546e-24fd-52a4a4004467\">See above (ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467)</a></p><p><b>status</b>: final</p><p><b>code</b>: Lyophilization Assay Homogeneity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Lyophilization Assay Homogeneity)</span></p><p><b>subject</b>: <a href=\"#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SSE "Statistically significant effects")</span></p><p><b>value</b>: No</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#LCL)</span></p><p><b>value</b>: Not calculated</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#UCL)</span></p><p><b>value</b>: Not calculated</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Homogeneity "Homogeneity demonstrated")</span></p><p><b>value</b>: Yes</p></blockquote></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467"
},
"status" : "final",
"code" : // ObservationDefinition/LyophilizationAssayHomogeneity
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Lyophilization Assay Homogeneity",
"display" : "Lyophilization Assay Homogeneity"
}
],
"text" : "Lyophilization Assay Homogeneity"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"component" : [
// Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SSE",
"display" : "Statistically significant effects"
}
],
"text" : "Do statistically significant effects"
},
"valueString" : "No"
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "LCL",
"display" : "Lower one-sided 95% confidence limit of Max Difference"
}
]
},
"valueString" : "Not calculated"
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "UCL",
"display" : "Upper one-sided 95% confidence limit of Max Difference"
}
],
"text" : "Upper one-sided 95% confidence limit of Max Difference"
},
"valueString" : "Not calculated"
},
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Homogeneity",
"display" : "Homogeneity demonstrated"
}
],
"text" : "Was Homogeneity demonstrated?"
},
"valueString" : "Yes"
}
]
}
},
// boolean?
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : // Section 1.1 - DP Identification
{
"resourceType" : "MedicinalProductDefinition",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"text" : // medicinalproductdefinition-drug-product-pq-ex1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-local-pq.html\">CodeSystem - Product Name Type</a>#Proprietary)</span></p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>20mg</td><td>Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html\">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>"
},
"description" : "Textual description of the product",
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10225000",
"display" : "Gastro-resistant tablet"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20053000",
"display" : "Oral use"
}
]
}
],
"name" : [
{
"productName" : "Stelbat Tablets, 20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq",
"code" : "Proprietary",
"display" : "Proprietary"
}
]
},
"part" : [
{
"part" : "20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "StrengthPart",
"display" : "Strength part"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
"resource" : {
"resourceType" : "Ingredient",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
"text" : // productIngredient
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" </p></div><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>role</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_6eb94d34-48b4-5bb0-4c05-e183d2ea3e95\">See above (SubstanceDefinition/6eb94d34-48b4-5bb0-4c05-e183d2ea3e95)</a></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
],
"role" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/6eb94d34-48b4-5bb0-4c05-e183d2ea3e95"
}
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:6eb94d34-48b4-5bb0-4c05-e183d2ea3e95",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "6eb94d34-48b4-5bb0-4c05-e183d2ea3e95",
"text" : // substance1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"6eb94d34-48b4-5bb0-4c05-e183d2ea3e95\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "6eb94d34-48b4-5bb0-4c05-e183d2ea3e95" </p></div><p><b>manufacturer</b>: <a href=\"#Organization_23dbbd32-2962-9fc3-40b1-67e864f21cd2\">See above (Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2"
}
],
"name" : [
// Organization/substance-manufacturer
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2",
"resource" : {
"resourceType" : "Organization",
"id" : "23dbbd32-2962-9fc3-40b1-67e864f21cd2",
"text" : // substance-manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"23dbbd32-2962-9fc3-40b1-67e864f21cd2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "23dbbd32-2962-9fc3-40b1-67e864f21cd2" </p></div><p><b>identifier</b>: id:\u00a03003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:57a9af63-315d-1585-a261-0e337b289390",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "57a9af63-315d-1585-a261-0e337b289390",
"meta" : // substancedefinition-component-substance-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"57a9af63-315d-1585-a261-0e337b289390\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html\">SubstanceDefinition - Component Substance Drug PQ</a></p></div><p><b>manufacturer</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
],
"name" : [
// Organization/organization-drug-pq-ex1
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c",
"resource" : {
"resourceType" : "Organization",
"id" : "49d2f0c0-4b28-9271-8aaf-2996a8b9739c",
"meta" : // id value="substance-manufacturer"/
// organization-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"49d2f0c0-4b28-9271-8aaf-2996a8b9739c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Organization-drug-pq.html\">Organization - Drug PQ</a></p></div><p><b>identifier</b>: id:\u00a03003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a",
"resource" : // another outer action can be the whole thing, if needed
// removed the main actions for brevity (see manufacturing example)
{
"resourceType" : "PlanDefinition",
"id" : "plandefinition-drug-pq-ex2-manufacturing-plan",
"meta" : // indicate this is as subset of the resource. In practice it would have it all
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
],
"tag" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-ObservationValue",
"code" : "SUBSETTED"
}
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex2-manufacturing-plan\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p><p style=\"margin-bottom: 0px\">Tag: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ObservationValue http://terminology.hl7.org/CodeSystem/v3-ObservationValue}\">http://terminology.hl7.org/CodeSystem/v3-ObservationValue</span></p></div><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: Process 1.0</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#manufacturing-process "Manufacturing Process")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>description</b>: Narrative description of manufacturing process (5)</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-pH</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - pH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>pH must be in range 6.9 to 7.1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH "pH")</span></td><td>6.9-7.1 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-water-content</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 2% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent "Water content")</span></td><td>?-2</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-particle-size</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 200 microns <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#particle-size "Particle Size")</span></td><td>?-200</td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#DeviceDefinition_82a39a18-91cf-a29d-76c1-a9e8bad9494d\">See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d)</a></td><td>Mixing Vessel <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-equipmentClass-local-pq.html\">CodeSystem - Equipment Class</a>#mixing-vessel)</span></td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#DeviceDefinition_82a39a18-91cf-b29d-76c1-a9e8bad9494d\">See above (DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d)</a></td><td>Receiving Vessel <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-equipmentClass-local-pq.html\">CodeSystem - Equipment Class</a>#receiving-vessel)</span></td></tr></table></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq",
"valueMarkdown" : "This can be text about the history"
}
],
"url" : "http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a",
"title" : "Process 1.0",
"type" : // http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq",
"code" : "manufacturing-process",
"display" : "Manufacturing Process"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
},
"description" : "Narrative description of manufacturing process (5)",
"goal" : [
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"id" : "goal-control-pH",
"category" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : // this is mandatory, even though we don't really want it
{
"text" : "Controls - pH"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "pH",
"display" : "pH"
}
],
"text" : "pH must be in range 6.9 to 7.1"
},
"detailRange" : // detailString value="can also be a string"
{
"low" : {
"value" : 6.9,
"unit" : "pH"
},
"high" : {
"value" : 7.1,
"unit" : "pH"
}
}
}
]
},
{
"id" : "goal-control-water-content",
"category" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : // this is mandatory, even though we don't really want it
{
"text" : "Controls - Water Content"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water content"
}
],
"text" : "Under 2%"
},
"detailRange" : // detailString value="can also be a string"
{
"high" : {
"value" : 2,
"unit" : "%"
}
}
}
]
},
{
"id" : "goal-control-particle-size",
"category" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq",
"code" : "C123456",
"display" : "Physical Property"
}
]
},
"description" : {
"text" : "Controls - Particle Size"
},
"priority" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq",
"code" : "critical",
"display" : "Critical"
}
]
},
"target" : [
{
"measure" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "particle-size",
"display" : "Particle Size"
}
],
"text" : "Under 200 microns"
},
"detailRange" : // detailString value="can also be a string"
{
"high" : {
"value" : 200,
"unit" : "microns"
}
}
}
]
}
],
"actor" : [
{
"option" : [
{
"typeReference" : {
"reference" : "DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d"
},
"role" : // DeviceDefinition/mixing-vessel
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq",
"code" : "mixing-vessel",
"display" : "Mixing Vessel"
}
]
}
}
]
},
{
"option" : [
{
"typeReference" : {
"reference" : "DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d"
},
"role" : // DeviceDefinition/receiving-tank
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq",
"code" : "receiving-vessel",
"display" : "Receiving Vessel"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-a29d-76c1-a9e8bad9494d",
"text" : // mixing-vessel
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a29d-76c1-a9e8bad9494d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d" </p></div><h3>DeviceNames</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Mixing Vessel</td><td>registered-name</td></tr></table><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Mixing Vessel <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceType-local-pq.html\">CodeSystem - Device Type</a>#mixing-vessel)</span></td></tr></table><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Capacity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceProperty-local-pq.html\">CodeSystem - Device Property</a>#Capacity)</span></td><td>1000 litres</td></tr></table></div>"
},
"deviceName" : [
{
"name" : "Mixing Vessel",
"type" : "registered-name"
}
],
"classification" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-local-pq",
"code" : "mixing-vessel",
"display" : "Mixing Vessel"
}
]
}
}
],
"property" : [
{
"type" : {
"coding" : [
// seems a little different to "maximum capacity
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq",
"code" : "Capacity",
"display" : "Capacity"
}
]
},
"valueQuantity" : {
"value" : 1000,
"unit" : "litres"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-b29d-76c1-a9e8bad9494d",
"text" : // receiving-tank
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-b29d-76c1-a9e8bad9494d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d" </p></div><h3>DeviceNames</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Receiving Tank</td><td>registered-name</td></tr></table><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Receiving Tank <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceType-local-pq.html\">CodeSystem - Device Type</a>#receiving-tank)</span></td></tr></table><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Capacity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-deviceProperty-local-pq.html\">CodeSystem - Device Property</a>#Capacity)</span></td><td>1200 litres</td></tr></table></div>"
},
"deviceName" : [
{
"name" : "Receiving Tank",
"type" : "registered-name"
}
],
"classification" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-local-pq",
"code" : "receiving-tank",
"display" : "Receiving Tank"
}
]
}
}
],
"property" : [
{
"type" : {
"coding" : [
// seems a little different to "maximum capacity
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq",
"code" : "Capacity",
"display" : "Capacity"
}
]
},
"valueQuantity" : {
"value" : 1200,
"unit" : "litres"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b",
"resource" : {
"resourceType" : "Substance",
"id" : "fc078762-81c5-5656-9744-13c7ad1e595b",
"meta" : // <id value="actual-batch-substance"/>
// substance-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"fc078762-81c5-5656-9744-13c7ad1e595b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Substance-drug-pq.html\">Substance - Drug PQ</a></p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT1</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_57a9af63-315d-1585-a261-0e337b289390\">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2019-09-07"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 5,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133991",
"display" : "Development"
}
]
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
}
]
},
// Organization/organization-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT1"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"
}
}
}
},
// SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1
{
"fullUrl" : "urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad",
"resource" : {
"resourceType" : "Substance",
"id" : "cb31d747-2338-88d5-342c-8e9c097e4dad",
"text" : // actual-batch-substance-2
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"cb31d747-2338-88d5-342c-8e9c097e4dad\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT2</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_57a9af63-315d-1585-a261-0e337b289390\">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2019-09-07"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 5,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133991",
"display" : "Development"
}
]
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
}
]
},
// Organization/organization-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT2"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"
}
}
}
},
// SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1
{
"fullUrl" : "urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c",
"resource" : {
"resourceType" : "Substance",
"id" : "1551f97b-6f6d-825e-1fb3-44b0b090808c",
"text" : // actual-batch-substance-3
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"1551f97b-6f6d-825e-1fb3-44b0b090808c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT3</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_57a9af63-315d-1585-a261-0e337b289390\">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2019-09-07"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 5,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133991",
"display" : "Development"
}
]
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
}
]
},
// Organization/organization-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT3"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"
}
}
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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