SpecimenReceiptAndReleaseMatcher

Specimen Receipt And Release Matcher

Vet veterinary veterinary vaccines animal health adjuvants aquaculture batch release CSV→JSON

Utility description: Specimen Receipt And Release Matcher

Specimen Receipt And Release Matcher — Biological Specimen Reconciliation and Receipt

ℹ️ Utility performs automated pre-analytical quality control upon receipt of biological specimens according to ISO 15189 and CLIA:
• Patient Identification: Strict reconciliation of data in requisition form and tube label.
• Suitability Assessment: Check for hemolysis, lipemia, leaks, and insufficient volume.
• Logistics: Control of time between collection and delivery, and temperature regime.
• Legal Compliance: Confirmation of informed patient consent presence.

⚠️ IMPORTANT:
• Pre-analytical phase accounts for up to 70% of all laboratory errors.
• Specimen with incorrect labeling must be immediately rejected to avoid identification errors.

Usage:
SpecimenReceiptAndReleaseMatcher.exe → demo mode (console output)
SpecimenReceiptAndReleaseMatcher.exe input.csv output.json → evaluate your data

Input format:
AccessionNumber,PatientID,PatientNameOnForm,PatientNameOnLabel,SpecimenType,ContainerType,CollectionTime,ReceiptTime,TransportTemp_C,IsLeaking,IsHemolyzed,ConsentPresent

Example:
ACC-001,PAT-1,John Doe,John Doe,Serum,SST,2026-01-01 08:00,2026-01-01 10:00,4.5,false,false,true

📍 Scope of Application (Usage Where):
• Laboratory Reception (Core Lab): Primary specimen registration.
• Courier Services: Quality check of biomaterial delivery.
• Point-of-Care Testing (POCT): Quality control before rapid testing.
• Reference Laboratories: Incoming control of specimens from external clinics.

— WHY IS THIS NEEDED?
Manual verification of each specimen is prone to personnel fatigue and human error.
Automation of data reconciliation and defect recording guarantees that only high-quality and correctly identified specimens go into analysis.
This is critically important for patient safety and diagnostic result accuracy.

⚠️ CRITICAL:
• Patient ID Mismatch: Any discrepancy in names or IDs requires re-collection of material.
• Leaking Containers: Pose biological hazard to laboratory personnel.
• Hemolysis: Red blood cell destruction distorts potassium, LDH, and other test results.
• Consent: Absence of consent makes testing illegal (except in emergencies).

Key features:
• Automatic reconciliation of textual and numeric identifiers
• Calculation of transport time in hours
• Status classification (Accepted/Rejected/Quarantine)
• Report generation on rejection reasons
• Compliance with international laboratory medicine standards

Critical parameters:
• Name Match: 100% match
• Integrity: No leaks
• Hemolysis Index: Negative
• Transport Time: Within analyte stability limits
• Consent: Present

💡 Usage tips:
1. Barcoding: Use scanners to minimize manual ID entry.
2. Courier Training: Inform delivery services about temperature requirements.
3. Feedback: Automatically send notifications to physicians about rejected specimens.
4. Documentation: Save reception logs as part of medical documentation.
5. Calibration: Regularly check reception department equipment (scales/thermometers).

⚠️ Note: This utility is an incoming control tool. It does not replace professional judgment of laboratory specialist or physician in complex clinical cases but ensures strictness of standard procedures.

input.csv

AccessionNumber,PatientID,PatientNameOnForm,PatientNameOnLabel,SpecimenType,ContainerType,CollectionTime,ReceiptTime,TransportTemp_C,IsLeaking,IsHemolyzed,ConsentPresent
ACC-2026-001,PAT-1001,John Doe,John Doe,Serum,SST,2026-06-08 08:00:00,2026-06-08 10:00:00,4.5,false,false,true
ACC-2026-002,PAT-1002,Jane Smith,Janet Smyth,Whole Blood,EDTA,2026-06-07 18:00:00,2026-06-08 09:00:00,22.0,true,true,true
ACC-2026-003,PAT-1003,Alice Wonder,Alice Wonder,Urine,Sterile Cup,2026-06-08 07:00:00,2026-06-08 08:30:00,20.0,false,false,false

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of SpecimenReceiptAndReleaseMatcher for Specimen Receipt And Release Matcher.

Domain limits URS input.csv FS IQ/OQ/PQ

Domain limits and critical parameters

Key fragments from the source description are shown below. Before production use, limits must be verified against the approved specification, registration dossier and local SOPs.

ℹ️ Utility performs automated pre-analytical quality control upon receipt of biological specimens according to ISO 15189 and CLIA:
• Specimen with incorrect labeling must be immediately rejected to avoid identification errors.
This is critically important for patient safety and diagnostic result accuracy.
⚠️ CRITICAL:
Critical parameters:
• Transport Time: Within analyte stability limits

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept an input.csv file for Specimen Receipt And Release Matcher with headers defined in the data contract.	High	The file is processed without manual header editing.
URS-002	The utility shall perform deterministic QC evaluation without machine learning and without probabilistic conformance decisions.	High	Identical input data, rule version and configuration produce reproducible results.
URS-003	The utility shall validate mandatory fields, data types, ranges, units and domain plausibility.	High	Schema, conversion and range errors are explicitly reported.
URS-004	The utility shall apply domain limits and rules from the description, approved specification, registration dossier and local SOPs.	High	Each check has PASS/WARNING/FAIL and a clear message.
URS-005	The utility shall generate output.json with machine-readable results, source values, warnings, failures and critical findings.	High	JSON is suitable for LIMS/ELN/MES integration and QA/QC review.
URS-006	The utility shall preserve traceability between batch/sample, input file, applied rules and final status.	High	Output contains identifiers, checked parameters and audit metadata.
URS-007	The documentation shall support IQ/OQ/PQ, CSV/CSA and review by internal QA or inspectors.	Medium	URS, FS, input/output contract and test scenarios are supplied with the utility.
URS-008	The utility shall be used as a QC decision-support tool and not as a substitute for approved specifications and QA/QP release decision.	Medium	Documentation states change control and limit-verification expectations.

input.csv contract

#	Field	Type	Sample	Purpose
1	`AccessionNumber`	string / controlled vocabulary	`ACC-2026-001`	Controlled input parameter for deterministic QC rules.
2	`PatientID`	string / controlled vocabulary	`PAT-1001`	Controlled input parameter for deterministic QC rules.
3	`PatientNameOnForm`	string / controlled vocabulary	`John Doe`	Controlled input parameter for deterministic QC rules.
4	`PatientNameOnLabel`	string / controlled vocabulary	`John Doe`	Controlled input parameter for deterministic QC rules.
5	`SpecimenType`	string / controlled vocabulary	`Serum`	Controlled input parameter for deterministic QC rules.
6	`ContainerType`	string / controlled vocabulary	`SST`	Controlled input parameter for deterministic QC rules.
7	`CollectionTime`	string / controlled vocabulary	`2026-06-08 08:00:00`	Time parameter for process, incubation, storage or analytical workflow.
8	`ReceiptTime`	string / controlled vocabulary	`2026-06-08 10:00:00`	Time parameter for process, incubation, storage or analytical workflow.
9	`TransportTemp_C`	decimal	`4.5`	Temperature profile/MKT; storage, shipping and stability parameter.
10	`IsLeaking`	string / controlled vocabulary	`false`	Controlled input parameter for deterministic QC rules.
11	`IsHemolyzed`	string / controlled vocabulary	`false`	Controlled input parameter for deterministic QC rules.
12	`ConsentPresent`	string / controlled vocabulary	`true`	Controlled input parameter for deterministic QC rules.

AccessionNumber,PatientID,PatientNameOnForm,PatientNameOnLabel,SpecimenType,ContainerType,CollectionTime,ReceiptTime,TransportTemp_C,IsLeaking,IsHemolyzed,ConsentPresent
ACC-2026-001,PAT-1001,John Doe,John Doe,Serum,SST,2026-06-08 08:00:00,2026-06-08 10:00:00,4.5,false,false,true
ACC-2026-002,PAT-1002,Jane Smith,Janet Smyth,Whole Blood,EDTA,2026-06-07 18:00:00,2026-06-08 09:00:00,22.0,true,true,true
ACC-2026-003,PAT-1003,Alice Wonder,Alice Wonder,Urine,Sterile Cup,2026-06-08 07:00:00,2026-06-08 08:30:00,20.0,false,false,false

Input validation rules

ID	Field	Rule	Criticality
VR-001	`AccessionNumber`	The field shall match an approved dictionary or accepted string representation.	High
VR-002	`PatientID`	The field shall match an approved dictionary or accepted string representation.	High
VR-003	`PatientNameOnForm`	The field shall match an approved dictionary or accepted string representation.	High
VR-004	`PatientNameOnLabel`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-005	`SpecimenType`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-006	`ContainerType`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-007	`CollectionTime`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-008	`ReceiptTime`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-009	`TransportTemp_C`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-010	`IsLeaking`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-011	`IsHemolyzed`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-012	`ConsentPresent`	The field shall match an approved dictionary or accepted string representation.	Medium

FS — Functional Specification

ID	Function	Implementation
FS-001	CLI execution	Support execution modes: demo mode without arguments and production mode input.csv output.json.
FS-002	CSV import	Read input.csv in UTF-8/CSV-compatible format and validate header and expected columns.
FS-003	Schema validation	Check mandatory fields, column count, unknown key fields and empty mandatory values.
FS-004	Type conversion	Convert numeric, flag and text values; invalid format is recorded as a row-level error.
FS-005	Domain rule engine	Apply rules for Specimen Receipt And Release Matcher, including critical limits from the description and approved specification.
FS-006	Status aggregation	Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance.
FS-007	JSON export	Write output.json with detailed checks, source values, warnings, failures and critical findings.
FS-008	Audit support	Keep result structure suitable for review, deviation investigation and calculation reproduction.
FS-009	Integration contract	Support the scenario LIMS/ELN/MES → input.csv → utility → output.json → portal/admin review.
FS-010	Error handling	Return explicit messages for missing file, empty CSV, invalid schema, output write failure and invalid format.

Example output.json

{
  "utilityId": "specimenreceiptandreleasematcher",
  "utilityFolder": "SpecimenReceiptAndReleaseMatcher",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "AccessionNumber",
      "value": "ACC-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "PatientID",
      "value": "PAT-1001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "PatientNameOnForm",
      "value": "John Doe",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "PatientNameOnLabel",
      "value": "John Doe",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "SpecimenType",
      "value": "Serum",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "ContainerType",
      "value": "SST",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "CollectionTime",
      "value": "2026-06-08 08:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "ReceiptTime",
      "value": "2026-06-08 10:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "TransportTemp_C",
      "value": "4.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "IsLeaking",
      "value": "false",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "IsHemolyzed",
      "value": "false",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "ConsentPresent",
      "value": "true",
      "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": "SpecimenReceiptAndReleaseMatcher.documentation.html"
  }
}

Traceability matrix

URS	FS	Test	Evidence
URS-001	FS-001, FS-002	OQ-001	Verify execution and import of valid input.csv.
URS-002	FS-005, FS-006	OQ-004	Repeat the same dataset and compare output.json.
URS-003	FS-003, FS-004, FS-010	OQ-002, OQ-003	Verify missing columns and invalid types.
URS-004	FS-005, FS-006	OQ-004, PQ-001	Verify critical deviations on real/boundary data.
URS-005	FS-007, FS-009	OQ-005	Verify JSON schema and downstream-system suitability.
URS-006	FS-008	OQ-006	Verify identifiers and audit metadata.
URS-007	FS-008, FS-010	IQ-001, OQ-007	Verify documentation completeness and control evidence.
URS-008	FS-005, FS-008	PQ-002	Verify review workflow and no replacement of QA decision.

IQ/OQ/PQ test scenarios

ID	Scenario	Expected result
IQ-001	Verify executable, input.csv, documentation and checksum availability.	Delivery set is complete; version is recorded.
OQ-001	Valid sample row from input.csv.	PASS or acceptable WARNING according to rules.
OQ-002	Remove a mandatory CSV column.	Schema error or FAIL with missing-column reference.
OQ-003	Place a non-numeric value into a numeric field.	Type-conversion error with row/field reference.
OQ-004	Set a critical parameter outside the limit.	FAIL and critical finding.
OQ-005	Verify output.json structure.	All mandatory sections are present and JSON is valid.
OQ-006	Verify batch/sample traceability.	Input and result identifiers match.
PQ-001	Verify 3–5 real user batches/samples.	Result is confirmed by QC/QA review.
PQ-002	Verify deviation workflow and manual QA decision.	Utility supports review but does not replace approved decision.

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.

Included in packages

Vet — Veterinary QC Utilities

Vet is designed for veterinary pharmaceuticals and vaccines: adjuvants, antigens, autogenous vaccines, aquaculture, feed/premixes, antimicrobial and antiparasitic products, sterility and batch release.

Open