SendoutSampleChainChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of SendoutSampleChainChecker for Sendout Sample Chain Checker.

Domain limits and critical parameters

• Performs sendout traceability verification per CAP/CLIA §GEN.48800, ISO 15189 §7.3.2, CLSI GP44-A2 and Joint Commission NPSG.01.01.01: order documentation (requisition, clinical info, consent, insurance auth), courier handoff (packaging, manifest, tracking number, handoff confirmation), transit monitoring (tracking status, delivery confirmation, transit duration vs max), ref lab receipt (accession confirmation, test match, sample condition, rejection reason), result return verification (performe
• ⚠️ Critical: Sendout samples have HIGHEST identity loss risk due to multiple transfer points. Missing courier handoff confirmation = cannot prove shipment. Tracking exception without delivery = presume LOST. Result with mismatched PatientID/SampleID = potential wrong-patient error. Different test performed than ordered = clinically inapplicable result. SLA breach without notification = service agreement and ethical violation. Every chain gap must be documented and investigated. Tool verifies CHA
• • CAP/ISO accreditation: Chain of custody documentation for external tests.
• ⚠️ Note: This utility verifies CHAIN TRACEABILITY, not result quality. Clinical result verification is performed separately. For RESULT_MISMATCH or LOST_IN_TRANSIT status, all result-related actions must be blocked until the issue is resolved. Decisions regarding sample re-submission are made jointly by the ordering physician and laboratory director.

URS — User Requirements Specification

input.csv contract

SampleID,PatientID,OrderingFacility,ReferenceLab,OrderedTest,Priority,RequisitionForm_Complete,ClinicalInformation_Provided,InformedConsent_Documented,InsuranceAuthorization_Obtained,OrderDate,AuthorizedBy,SamplePackaged_Correctly,ShippingManifest_Generated,CourierTrackingNumber,HandoffToCourier_DateTime,HandoffConfirmed_ByCourier,HandoffPerson_ID,TransitTracking_Active,LastTrackingStatus,ExpectedDelivery_DateTime,ActualDelivery_DateTime,DeliveryConfirmed_ByRefLab,TransitDuration_Hours,MaxExpectedTransit_Hours,RefLab_AccessionNumber,RefLab_Accession_Confirmed,RefLab_Received_DateTime,RefLab_TestOrdered_Matches,RefLab_SampleCondition_Acceptable,RefLab_RejectionReason,Result_Received,Result_Received_DateTime,PerformedTest_Name,PerformedTest_Matches_Ordered,Result_PatientID_Matches,Result_SampleID_Matches,Result_Status,Result_Interpretation_Included,TargetTAT_Hours,ActualTAT_Hours,SLA_Met,SLABreach_Notified,ResidualSample_ReturnRequested,ResidualSample_Returned,ResidualReturn_DateTime,MissingHandoffSteps,AnyIdentityMismatch,UnexplainedDelay_Detected,GapDescription
SO-2026-001,PAT-LUNG-042,City Hospital,National Genetics Lab,BRCA1_2_Full_Sequencing,Routine,true,true,true,true,2026-05-28,Dr. Petrov,true,true,TRK-889900,2026-05-28T10:00:00,true,TECH-012,true,Delivered,2026-05-29T12:00:00,2026-05-29T11:30:00,true,25.5,48,NGL-2026-44521,true,2026-05-29T11:30:00,true,true,,true,2026-06-05T14:00:00,BRCA1_2_Full_Sequencing,true,true,true,Final,true,168,196,false,true,true,true,2026-06-07T09:00:00,0,false,false,
SO-2026-002,PAT-CRC-055,Regional Oncology,Molecular Diagnostics Inc,MSI_Stability_Panel,STAT,true,true,true,true,2026-06-01,Dr. Sidorova,true,true,TRK-112233,2026-06-01T08:00:00,true,TECH-008,true,Exception,2026-06-02T10:00:00,,false,0,24,,false,,,false,false,,false,,,,,,,72,0,false,false,false,false,,3,false,true,No delivery confirmation; tracking exception; ref lab has no record
SO-2026-003,PAT-BRCA-061,Women's Health Center,Hereditary Cancer Lab,PALB2_Single_Gene,Routine,true,true,true,true,2026-05-20,Dr. Ivanova,true,true,TRK-445566,2026-05-20T14:00:00,true,TECH-015,true,Delivered,2026-05-21T16:00:00,2026-05-21T15:45:00,true,25.75,48,HCL-2026-78901,true,2026-05-21T15:45:00,false,true,,true,2026-06-03T10:00:00,BRCA1_2_Panel,false,true,true,Final,true,168,332,false,true,false,false,,0,false,false,Performed test does not match ordered test

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "sendoutsamplechainchecker",
  "utilityFolder": "SendoutSampleChainChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "SampleID",
      "value": "SO-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "PatientID",
      "value": "PAT-LUNG-042",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "OrderingFacility",
      "value": "City Hospital",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "ReferenceLab",
      "value": "National Genetics Lab",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "OrderedTest",
      "value": "BRCA1_2_Full_Sequencing",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "Priority",
      "value": "Routine",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "RequisitionForm_Complete",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "ClinicalInformation_Provided",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "InformedConsent_Documented",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "InsuranceAuthorization_Obtained",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "OrderDate",
      "value": "2026-05-28",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "AuthorizedBy",
      "value": "Dr. Petrov",
      "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": "SendoutSampleChainChecker.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.