ReferenceLabBatchReviewChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of ReferenceLabBatchReviewChecker for Reference Lab Batch Review Checker.

Domain limits and critical parameters

• Performs end-to-end pre-release verification per CAP/CLIA §GEN.48800, ISO 15189 §7.4, CLSI GP44 and accreditation standards: pre-analytical verification (accessioning, order match, demographics, sample type, rejection criteria), analytical QC (run QC, controls, calibration, reagent lot, maintenance), post-analytical verification (results completeness, interpretation review, variant classification, critical values, reflex testing, discrepancy resolution), report compliance (format, required eleme
• ⚠️ Critical: Reference lab bears responsibility for ALL stages including client pre-analytics. Order mismatch = potential patient misidentification; immediate investigation required. Missing e-signature or director review = legally invalid result. SLA breach without notification = service agreement and regulatory violation. PT must be current FOR EACH test performed; gap = testing suspension. Accreditation scope must cover test; out-of-scope = cannot be released as clinical. Dual sign-out mandat

URS — User Requirements Specification

input.csv contract

BatchID,OrderingFacility,AssayName,ReceivedDate,CompletedDate,TotalSamples,SampleAccessioning_Verified,OrderMatch_Verified,PatientDemographics_Matched,SampleType_Appropriate,RejectionCriteria_Checked,SamplesRejected_PreAnalytical,RunQC_Passed,Controls_AllPassed,Calibration_Current,ReagentLot_Verified,InstrumentMaintenance_Current,SamplesFailed_Analytical,SamplesRetested,ResultsEntered_Complete,Interpretation_Reviewed,VariantClassification_Verified,CriticalValues_Flagged,ReflexTesting_Triggered_Correctly,AddendumRequired_Flagged,ResultsWithDiscrepancies,ReportFormat_Compliant,RequiredElements_Present,UnitsAndRefRanges_Correct,Disclaimer_Included,Language_Appropriate,DirectorReview_Completed,AuthorizedSigner_ID_Verified,ElectronicSignature_Applied,SignerCredentials,DualSignout_Required,DualSignout_Completed,TargetTAT_Hours,ActualTAT_Hours,SLA_Met,Priority,SLABreach_Notified,AuditTrail_Complete,Amendments_Documented,ProficiencyTesting_Current,AccreditationScope_Covers_Assay,ClientSpecificRequirements_Met
REF-BATCH-2026-0142,City Hospital Oncology,NSCLC_CGP_Panel,2026-06-01,2026-06-07,24,true,true,true,true,true,1,true,true,true,true,true,0,1,true,true,true,true,true,false,0,true,true,true,true,true,true,true,true,MD, PhD,false,false,168,144,true,Routine,false,true,true,true,true,true
REF-BATCH-2026-0143,Regional Cancer Center,BRCA1_2_Germline,2026-05-25,2026-06-09,16,true,true,true,true,true,0,true,true,true,true,true,2,2,true,true,false,true,true,true,3,true,true,true,true,true,false,false,false,,true,false,168,360,false,Routine,true,true,false,true,true,true

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "referencelabbatchreviewchecker",
  "utilityFolder": "ReferenceLabBatchReviewChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchID",
      "value": "REF-BATCH-2026-0142",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "OrderingFacility",
      "value": "City Hospital Oncology",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "AssayName",
      "value": "NSCLC_CGP_Panel",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "ReceivedDate",
      "value": "2026-06-01",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "CompletedDate",
      "value": "2026-06-07",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "TotalSamples",
      "value": "24",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "SampleAccessioning_Verified",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "OrderMatch_Verified",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "PatientDemographics_Matched",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "SampleType_Appropriate",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "RejectionCriteria_Checked",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "SamplesRejected_PreAnalytical",
      "value": "1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "ReferenceLabBatchReviewChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation and test set.
• Retain input.csv, output.json, executable version and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.