LaboratoryResult

Laboratory test result containing measured values, units, clinical interpretation, and reference ranges. Supports quantitative, qualitative, and coded results with critical value flagging and validation workflows.

Overview

LaboratoryResult captures the outcome of a single laboratory test. It includes the measured value (numeric, text, or coded), units, clinical interpretation (normal/abnormal/critical), and applicable reference ranges. The entity tracks the result lifecycle from preliminary through final, with validation by qualified professionals. Critical values trigger immediate notification workflows.

Key Concepts

Result Status

The status field tracks result lifecycle:

StatusDescriptionClinical Use
registeredSpecimen receivedNot yet tested
preliminaryPending verificationUse with caution
finalValidatedActionable
amendedModified after finalCheck updates
correctedError correctedUse corrected value
cancelledCancelledNo result

Value Types

Results can be expressed multiple ways:

FieldTypeUse Case
valueQuantity + valueUnitNumberGlucose: 95 mg/dL
valueStringTextCulture: "Staph aureus identified"
valueCodeCodedHIV: Positive (SNOMED)

Clinical Interpretation

The interpretation field provides clinical context:

InterpretationMeaningAlert Level
normalWithin reference rangeNone
abnormalOutside range (unspecified)Review
highAbove upper limitReview
lowBelow lower limitReview
critical-highDangerously elevatedImmediate
critical-lowDangerously decreasedImmediate
positiveFinding presentVaries
negativeFinding absentNone
indeterminateCannot determineRepeat

Reference Ranges

The referenceRange array provides interpretation context:

  • Normal ranges for comparison
  • Critical thresholds for alerting
  • May vary by age, sex, pregnancy
  • Linked to patient demographics

Critical Values

Life-threatening results requiring immediate action:

  • isCritical - Boolean flag
  • criticalNotifiedDateTime - When provider notified
  • Mandatory notification protocols
  • Documented read-back
  • Time-sensitive

Specimen Link

The specimen field references Specimen:

  • What was tested
  • Collection details
  • Quality assessment
  • Chain of custody

Testing Method

The method field documents the procedure:

  • Analytical technique used
  • May affect interpretation
  • Supports quality review
  • Required for some results

Validation

Quality assurance:

  • validatedBy - Reviewing professional
  • validatedDateTime - When validated
  • Required before final status
  • Ensures accuracy

Timing

Important timestamps:

  • effectiveDateTime - When specimen collected
  • issued - When result released
  • Affects clinical interpretation
  • Supports turnaround metrics

Use Cases

Quantitative Result

For numeric measurements:

  1. Run analysis on specimen
  2. Record valueQuantity and valueUnit
  3. Compare to reference range
  4. Set interpretation based on comparison
  5. Flag if critical
  6. Validate and release

Qualitative Result

For categorical findings:

  1. Perform test (e.g., culture)
  2. Record valueString with description
  3. Set valueCode if applicable
  4. Interpret as positive/negative
  5. Add detailed notes
  6. Validate and release

Critical Value

When result is critical:

  1. Set isCritical: true
  2. Set interpretation (critical-high/low)
  3. Immediately notify provider
  4. Document criticalNotifiedDateTime
  5. Perform read-back verification
  6. Release as preliminary or final

Result Amendment

When correction needed:

  1. Change status to amended or corrected
  2. Update value if changed
  3. Document reason in notes
  4. Re-validate
  5. Notify ordering provider
  6. Preserve audit trail

Trend Analysis

For longitudinal review:

  1. Query results by patient and test
  2. Display values over time
  3. Show reference ranges
  4. Highlight abnormal trends
  5. Support clinical decisions

Related Entities

EntityRelationshipDescription
PatientReferencesWhose result this is
EncounterReferencesVisit context
LaboratoryOrderReferencesOriginal order
LabTestReferencesTest definition
SpecimenReferencesSpecimen tested
FacilityReferencesPerforming lab
PractitionerReferencesValidator
ReferenceRangeContains manyNormal/critical ranges
CodingContainsMethod and value codes
ClinicalIdentifierContainsResult identifiers
LaboratoryPanelReferenced byPanel containing this result

Calculated Fields

FieldTypeDescription
isAbnormalbooleanTrue when interpretation is not normal
isFinalbooleanTrue when status is final

Enums

status

ValueDescription
registeredSpecimen received, testing not yet started
preliminaryResults available but pending final verification
finalResult verified, validated, and ready for clinical use
amendedResult modified after being finalized
correctedResult corrected due to error in original value
cancelledTesting cancelled, no result generated
entered-in-errorResult created in error
unknownResult status cannot be determined

interpretation

ValueDescription
normalResult within normal reference range
abnormalResult outside normal limits (direction unspecified)
highResult above upper reference limit
lowResult below lower reference limit
critical-highResult dangerously elevated, requires immediate notification
critical-lowResult dangerously decreased, requires immediate notification
positiveFinding is present (for qualitative tests)
negativeFinding is absent (for qualitative tests)
indeterminateResult cannot be definitively interpreted
24 properties
Schema

Properties

PropertyTypeModeDescriptionRequired
identifierClinicalIdentifier[]
stored

Collection of unique business identifiers assigned to this laboratory result by various systems, laboratories, or organizations for tracking and reference purposes

Example: [{"system":"http://hospital.example.org/lab-results","value":"LAB-2024-00123456"}]

Optional
patientPatient
stored

Reference to the patient for whom this laboratory test was performed and to whom the results apply

Required
encounterEncounter
stored

Reference to the healthcare encounter or visit during which this laboratory test was ordered or specimen was collected

Optional
orderLaboratoryOrder
stored

Reference to the laboratory order that requested this test and which this result fulfills

Optional
statusstring
stored

Current workflow status of the laboratory result, indicating the stage of completion and reliability of the result data

Values: registered, preliminary, final, amended, corrected, cancelled, entered-in-error, unknown

Example: "final"

Required
codeLabTest
stored

Reference to the standardized laboratory test definition indicating which test was performed, typically using LOINC or other coding systems

Required
effectiveDateTimeDateTime
stored

Date and time when the specimen was collected from the patient, representing the clinically relevant time for the measurement

Optional
issuedDateTime
stored

Date and time when the laboratory result was published, released, or made available to clinicians

Optional
performerFacility
stored

Reference to the laboratory facility or organization that performed the test and generated the result

Optional
valueQuantitynumber
stored

Numeric value of the laboratory measurement for quantitative results

Optional
valueUnitstring
stored

Unit of measurement for the numeric result value (e.g., mg/dL, mEq/L, g/dL)

Optional
valueStringstring
stored

Textual representation of the result for qualitative or descriptive findings

Optional
valueCodeCoding
stored

Coded representation of the result value for categorical findings such as positive/negative, reactive/non-reactive, or other standardized result codes

Example: {"code":"10828004","display":"Positive","system":"http://snomed.info/sct"}

Optional
interpretationstring
stored

Clinical interpretation or assessment of the result value in relation to reference ranges and clinical significance

Values: normal, abnormal, high, low, critical-high, critical-low, positive, negative, indeterminate

Example: "normal"

Optional
referenceRangeReferenceRange[]
stored

Collection of reference ranges providing normal, therapeutic, or critical value boundaries applicable to this result for comparison and interpretation

Example: [{"low":{"value":70,"unit":"mg/dL"},"high":{"value":100,"unit":"mg/dL"},"type":"normal","text":"Normal fasting glucose range"}]

Optional
methodCoding
stored

Laboratory methodology or technique used to perform the test, providing procedural context for result interpretation

Example: {"code":"enzymatic","display":"Enzymatic colorimetric assay","system":"http://terminology.hl7.org/CodeSystem/observation-method"}

Optional
specimenSpecimen
stored

Reference to the biological specimen that was analyzed to produce this laboratory result

Optional
notestring
stored

Additional comments, annotations, or interpretive notes from the pathologist or laboratory technician regarding the result

Optional
isCriticalboolean
stored

Flag indicating whether this result contains a critical value that requires immediate notification to the ordering provider or clinical team

Optional
criticalNotifiedDateTimeDateTime
stored

Date and time when the critical value was communicated to the responsible healthcare provider, fulfilling regulatory notification requirements

Optional
validatedByPractitioner
stored

Reference to the pathologist, laboratory director, or qualified professional who validated and approved the result for clinical use

Optional
validatedDateTimeDateTime
stored

Date and time when the result was validated and approved by the responsible laboratory professional

Optional
isAbnormalboolean
calculated

Calculated indicator of whether the result interpretation is abnormal, derived from the interpretation field being any value other than 'normal'

Optional
isFinalboolean
calculated

Calculated indicator of whether the result status is final, signifying that the result is complete, validated, and ready for clinical decision-making

Optional

Examples

Example 1

{
  "@type": "LaboratoryResult",
  "identifier": [
    {
      "system": "http://hospital.example.org/lab-results",
      "value": "LAB-2024-00123456"
    }
  ],
  "patient": "Patient/patient-123",
  "encounter": "Encounter/encounter-456",
  "order": "LaboratoryOrder/order-789",
  "status": "final",
  "code": "LabTest/glucose-serum",
  "effectiveDateTime": "2024-11-30T08:30:00Z",
  "issued": "2024-11-30T10:15:00Z",
  "performer": "Facility/lab-central",
  "valueQuantity": 95,
  "valueUnit": "mg/dL",
  "interpretation": "normal",
  "referenceRange": [
    {
      "low": {
        "value": 70,
        "unit": "mg/dL",
        "system": "http://unitsofmeasure.org",
        "code": "mg/dL"
      },
      "high": {
        "value": 100,
        "unit": "mg/dL",
        "system": "http://unitsofmeasure.org",
        "code": "mg/dL"
      },
      "type": "normal",
      "text": "Normal fasting glucose range for adults",
      "appliesTo": [
        "adult"
      ]
    }
  ],
  "method": {
    "code": "enzymatic",
    "display": "Enzymatic colorimetric assay",
    "system": "http://terminology.hl7.org/CodeSystem/observation-method"
  },
  "specimen": "Specimen/specimen-001",
  "isCritical": false,
  "validatedBy": "Practitioner/pathologist-dr-jones",
  "validatedDateTime": "2024-11-30T10:10:00Z",
  "_comment": "isAbnormal: false, isFinal: true"
}

Example 2

{
  "@type": "LaboratoryResult",
  "identifier": [
    {
      "system": "http://hospital.example.org/lab-results",
      "value": "LAB-2024-00123457"
    }
  ],
  "patient": "Patient/patient-124",
  "encounter": "Encounter/encounter-457",
  "order": "LaboratoryOrder/order-790",
  "status": "final",
  "code": "LabTest/potassium-serum",
  "effectiveDateTime": "2024-11-30T09:00:00Z",
  "issued": "2024-11-30T11:00:00Z",
  "performer": "Facility/lab-central",
  "valueQuantity": 5.8,
  "valueUnit": "mEq/L",
  "interpretation": "high",
  "referenceRange": [
    {
      "low": {
        "value": 3.5,
        "unit": "mEq/L",
        "system": "http://unitsofmeasure.org",
        "code": "meq/L"
      },
      "high": {
        "value": 5,
        "unit": "mEq/L",
        "system": "http://unitsofmeasure.org",
        "code": "meq/L"
      },
      "type": "normal",
      "text": "Normal potassium range for adults",
      "appliesTo": [
        "adult"
      ]
    }
  ],
  "specimen": "Specimen/specimen-002",
  "note": "Elevated potassium level. Recommend repeat testing and review of medications. Rule out hemolysis.",
  "isCritical": false,
  "validatedBy": "Practitioner/pathologist-dr-jones",
  "validatedDateTime": "2024-11-30T10:55:00Z",
  "_comment": "isAbnormal: true, isFinal: true"
}

Example 3

{
  "@type": "LaboratoryResult",
  "identifier": [
    {
      "system": "http://hospital.example.org/lab-results",
      "value": "LAB-2024-00123458"
    }
  ],
  "patient": "Patient/patient-125",
  "encounter": "Encounter/encounter-458",
  "order": "LaboratoryOrder/order-791",
  "status": "final",
  "code": "LabTest/hemoglobin-blood",
  "effectiveDateTime": "2024-11-30T07:45:00Z",
  "issued": "2024-11-30T09:30:00Z",
  "performer": "Facility/lab-central",
  "valueQuantity": 6.5,
  "valueUnit": "g/dL",
  "interpretation": "critical-low",
  "referenceRange": [
    {
      "low": {
        "value": 12,
        "unit": "g/dL",
        "system": "http://unitsofmeasure.org",
        "code": "g/dL"
      },
      "high": {
        "value": 15.5,
        "unit": "g/dL",
        "system": "http://unitsofmeasure.org",
        "code": "g/dL"
      },
      "type": "normal",
      "text": "Normal hemoglobin range for adult females",
      "appliesTo": [
        "adult",
        "female"
      ]
    },
    {
      "low": {
        "value": 7,
        "unit": "g/dL",
        "system": "http://unitsofmeasure.org",
        "code": "g/dL"
      },
      "type": "critical",
      "text": "Critical low hemoglobin threshold",
      "appliesTo": [
        "adult"
      ]
    }
  ],
  "specimen": "Specimen/specimen-003",
  "note": "CRITICAL LOW HEMOGLOBIN. Severe anemia requiring immediate clinical intervention. Consider transfusion.",
  "isCritical": true,
  "criticalNotifiedDateTime": "2024-11-30T09:35:00Z",
  "validatedBy": "Practitioner/pathologist-dr-smith",
  "validatedDateTime": "2024-11-30T09:25:00Z",
  "_comment": "isAbnormal: true, isFinal: true"
}

Example 4

{
  "@type": "LaboratoryResult",
  "identifier": [
    {
      "system": "http://hospital.example.org/lab-results",
      "value": "LAB-2024-00123459"
    }
  ],
  "patient": "Patient/patient-126",
  "encounter": "Encounter/encounter-459",
  "order": "LaboratoryOrder/order-792",
  "status": "final",
  "code": "LabTest/culture-blood",
  "effectiveDateTime": "2024-11-28T14:00:00Z",
  "issued": "2024-11-30T12:00:00Z",
  "performer": "Facility/lab-microbiology",
  "valueCode": {
    "code": "10828004",
    "display": "Positive",
    "system": "http://snomed.info/sct"
  },
  "valueString": "Staphylococcus aureus identified. Antibiotic sensitivity testing in progress.",
  "interpretation": "positive",
  "specimen": "Specimen/specimen-004",
  "note": "Positive blood culture after 24 hours incubation. Gram-positive cocci in clusters. Final identification: Staphylococcus aureus. Sensitivity results to follow.",
  "isCritical": true,
  "criticalNotifiedDateTime": "2024-11-29T08:15:00Z",
  "validatedBy": "Practitioner/microbiologist-dr-chen",
  "validatedDateTime": "2024-11-30T11:55:00Z",
  "_comment": "isAbnormal: true, isFinal: true"
}