F-QM-009-A-V0 — Laboratory Risk Register, Assessment, and Treatment Plan
Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.
Parent document: LAB-QM-009 — Risk Management Policy (parent is encoded in the form number)
Rendered in-browser from the project's Word file F-QM-009-A-V0-laboratory-risk-register-and-assessment-form.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.
| Document # | F-QM-009-A-V0 | Parent Document | LAB-QM-009 — Risk Management Policy |
|---|
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Part 1 — Assessment Identification & Operational Scope
| Field | Details |
|---|---|
| Assessment Tracking No.: | LRA-YYYY-____ |
| Date of Assessment: | YYYY-MM-DD |
| Facility Category: | Primary Clinical Laboratory (BSL-2) |
| Operational Domains Assessed: | [ ] Pre-Examination (Phlebotomy / Receiving) [ ] Analytical / Examination [ ] Post-Examination / LIS [ ] Biosafety & Chemical Safety [ ] Facility & Environmental Conditions |
| Assessment Lead: | Chief Medical Technologist / Laboratory Quality Manager |
| Clinical Oversight: | Pathologist / Head of Laboratory |
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Part 2 — Multi-Domain Hazard Identification & Risk Evaluation Matrix
Risk Score Formula: Likelihood (1: Rare to 5: Frequent) × Severity (1: Negligible to 5: Catastrophic) = Risk Score (1–25). Risk Level: Low (1–6), Medium (7–14), High (15–25).
| Risk ID | Operational Domain | Hazard / Potential Failure Mode | Root Cause / Mechanism | Consequence / Clinical Impact | Initial Score (L × S) | Existing Risk Controls | Residual Score | Treatment Action Required |
|---|---|---|---|---|---|---|---|---|
| RSK-01 | Pre-Examination | Patient or Specimen Mislabling | Distraction during phlebotomy or registration rush | Erroneous diagnostic result, wrong patient treatment | Medium (3 × 4 = 12) | Two-identifier check at phlebotomy, barcode/label bedside confirmation | Low (1 × 4 = 4) | Quarterly phlebotomy audit |
| RSK-02 | Examination | Reagent deterioration from cold chain break | Unnoticed power interruption or fridge door ajar | Falsely elevated/depressed patient test values | Medium (3 × 4 = 12) | Twice-daily manual temp logs, UPS backup on vaccine fridge, min/max thermometers | Low (1 × 3 = 3) | Weekly temp review |
| RSK-03 | Examination | Analytical drift on HORIBA ABX Pentra XL 80 | Laser or aperture contamination, control shift | Inaccurate CBC differential or platelet count | Medium (2 × 4 = 8) | Daily 2-level commercial IQC runs, Westgard evaluation, monthly bleach clean | Low (1 × 3 = 3) | Strict run rejection rule |
| RSK-04 | Post-Examination | Critical value telephone reporting delay | Unanswered ward phone or delay in finding doctor | Delayed emergency clinical intervention | Medium (3 × 4 = 12) | Read-back protocol, dedicated emergency landline, 15-minute escalation policy | Low (1 × 4 = 4) | Monthly TAT exception audit |
| RSK-05 | Biorisk & Safety | Needlestick injury / Bloodborne exposure | Recapping needle or overfilled sharps bin | HBV, HCV, or HIV transmission to laboratory staff | Medium (2 × 5 = 10) | Single-use safety-shield needles, rigid puncture-proof yellow bins at 3/4 fill | Low (1 × 4 = 4) | Free HBV vaccination & PPE |
| RSK-06 | Biorisk & Safety | Centrifuge aerosol release on tube breakage | Centrifuging uncapped tubes or unbalanced load | Inhalation exposure to respiratory or systemic pathogens | Medium (2 × 4 = 8) | Aerosol-tight sealed buckets, balanced loading, 30-min aerosol settling wait | Low (1 × 3 = 3) | Gasket integrity checks |
| RSK-07 | Facility & IT | Prolonged commercial power grid outage | Typhoon, severe weather, or grid maintenance | Halting of acute emergency testing in hospital | Medium (3 × 4 = 12) | Hospital standby generator (auto-transfer within 10s), dedicated analyzer UPS | Low (1 × 3 = 3) | Monthly generator load test |
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Part 3 — Controlled Risk Treatment Register & Action Tracking
Treatment plans for risks that need ongoing monitoring or engineering controls:
| Treatment Plan No. | Linked Risk ID | Planned Risk Treatment & Mitigation Actions | Assigned Responsible Person | Target Completion Date | Monitoring Frequency | Current Status | Effectiveness Verification |
|---|---|---|---|---|---|---|---|
| TP-2026-01 | RSK-01 | Implement standardized two-identifier pre-collection checklist on F-QM-PRE-001-A | CMT / Phlebotomist | Q1 2026 | Monthly | Implemented | Zero wrong-blood-in-tube events |
| TP-2026-02 | RSK-02 | Install digital min/max glycol-buffered temperature sensor in primary reagent fridge | CMT / Lab Aide | Q2 2026 | Daily | Implemented | Daily temp excursion = 0 |
| TP-2026-03 | RSK-05 | Conduct annual needle safety refresher and audit puncture-resistant container levels | Safety Officer / CMT | Q3 2026 | Quarterly | Ongoing | Zero needlestick incidents |
| TP-2026-04 | RSK-07 | Schedule quarterly UPS battery runtime and inverter capacity verification | IT / Maintenance Lead | Q4 2026 | Semi-Annual | Scheduled | Analyzer runtime verified >= 30 min |
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Part 4 — Risk Review, Residual Risk Acceptance & Annual Approvals
- [ ] All residual risks evaluated as Low (scores 1–6) are deemed clinically acceptable for primary clinical laboratory operations.
- [ ] No high-risk or unacceptable residual risks identified.
- [ ] Findings incorporated into the annual Quality Plan (F-QM-001-A-V0) and Management Review agenda (F-QM-013-A-V0).
| Role | Name | Signature | Date |
|---|---|---|---|
| Prepared by: Chief Medical Technologist / LQM | Junry, RMT | ||
| Reviewed & Approved by: Pathologist / Head of Laboratory | |||
| Acknowledged by: Hospital Director |