Proficiency Testing & External Quality Assessment¶
SENO participates in annual proficiency testing (PT) programs through accredited external providers and conducts regular internal quality assessments to verify the accuracy, reproducibility, and reliability of all testing methods. This dual-layer approach ensures objective, third-party verification of SENO's laboratory performance.
External PT Program Participation¶
SENO engages independent, accredited PT providers to evaluate performance across all core test types. Results are submitted to SENO's Quality Manager for review and, where applicable, certification bodies.
| Test Area | Provider Type | Frequency | Typical Panel Content | Samples Per Panel |
|---|---|---|---|---|
| PCR-based sex identification | External genetics PT provider | Annually (Q2) | 10 unknown DNA samples from known-sex birds | 10 |
| qPCR — pathogen detection (PBFD) | External molecular diagnostics PT | Annually (Q3) | 8 spiked positive samples + 2 negative controls | 10 |
| DNA extraction quality | Combined in PT panels | Annually | Measured yield (ng/µL), A260/280 purity ratio | Per provider |
| Quantitative qPCR accuracy | External PT provider | Bi-annually (from 2027) | Known-concentration BFDV plasmid standards | 6 |
Performance Metrics — Last 3 Years¶
SENO has maintained a 100% pass rate in all external PT assessments since 2023.
| Year | Assessment Type | Samples | Correct | Concordance | Notes |
|---|---|---|---|---|---|
| 2023 | DNA Sexing (CHD PCR) | 10 | 10/10 | 100% | All species correctly sexed |
| 2024 | DNA Sexing (CHD PCR) | 10 | 10/10 | 100% | Including challenging species (Eclectus, cockatoos) |
| 2024 | PBFD qPCR Detection | 10 | 10/10 | 100% | All positives detected; no false positives |
| 2025 | DNA Sexing (CHD PCR) | 10 | 10/10 | 100% | Panel included 3 rare species |
| 2025 | PBFD qPCR Detection | — | In progress | — | Testing for Q3 2026 |
Internal Proficiency Assessment¶
In addition to external PT, SENO conducts quarterly internal proficiency assessments designed to evaluate:
- Inter-operator reproducibility
- Inter-instrument consistency
- Random blind-sample accuracy
- Long-term assay drift monitoring
| Assessment | Frequency | Method | Passing Criterion | Last Result |
|---|---|---|---|---|
| Blind re-test | Quarterly | 5% of clinical samples randomly re-identified and re-tested by a different technician; results compared | 100% agreement in qualitative results | 100% (Q1 2026) |
| Technician comparison | Quarterly | Same panel of 10 samples tested independently by 2 different technicians on the same day | ≤ 1.5 Ct difference for qPCR; 100% qualitative agreement for conventional PCR | 0.8 Ct max diff (Q1 2026) |
| Inter-instrument comparison | Quarterly | Same panel of 8 samples tested on 2 different PCR/qPCR instruments | ≤ 1.0 Ct difference for qPCR; 100% agreement for conventional PCR | 0.6 Ct max diff (Q1 2026) |
| Long-term control monitoring | Continuous | Levey-Jennings charting of positive control Ct values across batches | No values outside mean ± 3 SD; ≤ 2 consecutive values outside ± 2 SD | In control (Q1 2026) |
| Extraction efficiency check | Monthly | Known-concentration control DNA extracted alongside clinical samples | Yield within ± 30% of expected; A260/280 = 1.8–2.0 | Pass (all months 2026) |
Inter-laboratory Exchange Program¶
SENO is establishing an inter-laboratory exchange program with partner laboratories to further validate cross-platform and cross-site reproducibility.
| Exchange Partner | Scope | Frequency | Status |
|---|---|---|---|
| Veterinary diagnostic laboratory (Asia) | DNA sexing concordance (50 matched samples) | Annually | Pilot completed — 100% concordance (2025) |
| Reference laboratory (Europe) | PBFD qPCR quantification comparison | Bi-annually | In discussion — target 2027 start |
Corrective Action Process (PT Discrepancy)¶
If a PT discrepancy is identified, SENO follows a structured Corrective and Preventive Action (CAPA) process:
| Step | Action | Owner | Timeline |
|---|---|---|---|
| 1 | Immediate investigation — QC team reviews all affected methods, reagents, and personnel | Quality Manager | Within 48 hours |
| 2 | Root cause analysis — using fishbone (Ishikawa) diagram and 5-Why methodology | Quality Manager + Lab Supervisor | Within 1 week |
| 3 | CAPA implementation — corrective actions documented and preventive measures defined | Quality Manager | Within 2 weeks |
| 4 | Client notification — for any affected clinical results (if applicable) | Quality Manager | Immediately upon confirmation |
| 5 | Re-validation — confirm correction through targeted re-validation before resuming clinical testing | R&D + QC | Per validation plan |
| 6 | Management review — CAPA outcome reviewed by senior management | Senior Management | Next management review meeting |
Note: To date, no PT discrepancy has occurred at SENO. The CAPA process is documented and tested as part of our ISO 13485 internal audit program.
Internal Audit of PT Records¶
PT participation and results are reviewed during:
| Review Type | Frequency | Review Focus |
|---|---|---|
| Internal QMS audit | Annual | PT documentation, result traceability, CAPA history |
| Management review | Semi-annual | PT performance trends, improvement opportunities |
| External surveillance audit | Annual (next: 2026) | PT records as evidence of QMS effectiveness |
Cross-References¶
- Accuracy Validation — Method validation framework and ongoing accuracy monitoring
- Laboratory QC Protocols — Per-batch, daily, and periodic QC procedures
- ISO 9001:2015 — Quality management system certification
- ISO 13485:2016 — Medical devices quality management certification
This document is maintained by SENO's Quality Management team. PT records are retained for a minimum of 5 years. For enquiries, contact [email protected].