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F-QM-010-A-V0 — Incident, Occurrence, and Deviation Report & Log

Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.

Parent document: LAB-QM-010 — Occurrence and Deviation Management Policy (parent is encoded in the form number)

Rendered in-browser from the project's Word file F-QM-010-A-V0-incident-occurrence-and-deviation-report.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.

Document #	F-QM-010-A-V0	Parent Document	LAB-QM-010 — Occurrence Management Policy

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# SECTION A — INCIDENT, OCCURRENCE & DEVIATION REPORT

Part 1 — Event Identification & Risk Classification

Complete immediately upon discovery (same shift or within 24 hours) and submit to CMT / LQM per LAB-QM-010 Section 5.3:

Field	Details
Report No.:	ORD-YYYY-____
Date & Time of Event:	YYYY-MM-DD / HH:MM
Date & Time Reported:	YYYY-MM-DD / HH:MM
Reporting Staff Member:	Full Name: ____________________________________ [ ] RMT [ ] Lab Aide [ ] Other: _________
Section Involved:	[ ] Hematology [ ] Clinical Microscopy [ ] Serology [ ] Phlebotomy / Receiving [ ] Facility / IT

1.1 Event Classification (Check One)

[ ] Occurrence / Nonconformance: Specimen defect, analyzer error, reagent fault, QC failure, clerical error.
[ ] Unplanned Deviation: Unscheduled equipment failure, power outage, emergency reagent substitution.
[ ] Planned Deviation: Pre-authorized, documented procedural alteration approved by Pathologist.
[ ] Near Miss: Latent error detected and intercepted before affecting patient result or clinical care.
[ ] Safety / Biohazard Incident: Biological spill, chemical splash, needlestick injury, waste breach.

1.2 Severity Level

[ ] Level 1 (Minor): No patient harm, no impact on result accuracy; immediate local correction.
[ ] Level 2 (Moderate): Minor reporting delay, recollection required; minimal clinical consequence.
[ ] Level 3 (Major): Erroneous result released, critical value delayed, or prolonged instrument shutdown.
[ ] Level 4 (Sentinel Event): Immediate threat to patient life, safety, or health; requires immediate Pathologist and Hospital Director notification.

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Part 2 — Event Description & Immediate Containment Taken

2.1 Factual Description of the Event

(Specify what happened, who was involved, equipment/specimen IDs involved. Never record full patient names in shared records; use MRN or Accession No.): ____________________________________________________________________________________________________ ____________________________________________________________________________________________________

2.2 Immediate Containment Actions Implemented

[ ] Patient specimen recollected or retested immediately.
[ ] Erroneous result withheld or amended clinical report issued per LAB-QM-POST-001.
[ ] Analyzer taken out of service, tagged out, and quarantined.
[ ] Affected reagent kit or batch quarantined.
[ ] Attending physician / clinical ward nurse notified immediately by phone.

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Part 3 — Investigation and Root-Cause Analysis (RCA)

Investigation Element	Findings & Evidence
Root Cause Category:	[ ] Human / Technique [ ] Reagent / Kit [ ] Equipment / Hardware [ ] LIS / IT [ ] Policy / Training
Direct Cause Identified:
Contributing Latent Factors:
Root Cause Conclusion:

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Part 4 — Corrective Actions, CAPA Escalation & Sign-Off

[ ] Resolved at Section Level: Local corrective action adequate; no systemic risk identified.
[ ] Systemic Nonconformance: Escalated to formal CAPA Record (F-QM-011-A-V0) | CAPA Ref No.: _________________

Role	Name	Signature	Date
Reporting Staff Member:
Investigated by (CMT / LQM):	Junry, RMT
Approved by (Pathologist):

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# SECTION B — INCIDENT & OCCURRENCE MASTER LOG

The Chief Medical Technologist / Laboratory Quality Manager maintains this central register of all events per LAB-QM-010:

Log No.	Date Reported	Report Ref No.	Event Classification	Severity Level (1–4)	Section	Brief Summary of Event	Immediate Action Taken	CAPA Ref (if applicable)	Status	Date Closed	Reviewer Initials
ORD-26-01									[ ] Open [ ] Closed
ORD-26-02									[ ] Open [ ] Closed
ORD-26-03									[ ] Open [ ] Closed
ORD-26-04									[ ] Open [ ] Closed
ORD-26-05									[ ] Open [ ] Closed

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Quarterly Occurrence Trend Review

The CMT / LQM and Pathologist review this quarterly for system-wide failure patterns and Management Review reporting:

Quarter / Year	Total Events Logged	Minor / Near Miss (Level 1/2)	Major / Sentinel (Level 3/4)	Recurring Causes Identified	System Improvements Initiated	Reviewed by (CMT & Pathologist)	Date
Q1 2026
Q2 2026
Q3 2026
Q4 2026