BML-QM-FRM-GEN-008-V01-Incident-Report

BONAVENTURE MEDICAL LABORATORY

Quality & Compliance | Customer Service: 242-829-8241 | bonaventurelab.com
INCIDENT REPORT FORM
SECTION 1 | REPORT IDENTIFICATION
Reported By
Date Filed

MonthDayYear
Date
Department / Section
Position / Title
Contact (Phone / Email)
Format: (000) 000-0000.
Date of Incident

MonthDayYear
Date
Date Discovered

MonthDayYear
Date
Time Discovered
Time of Incident
Witnesses
Location of Incident
List every person directly involved or affected. Add additional names on the Additional Notes page if needed.

Bonaventure Medical Laboratory Ltd. - Laboratory Professionals, Your Partners for Good Health.
BONAVENTURE MEDICAL LABORATORY

Quality & Compliance | Customer Service: 242-829-8241 | bonaventurelab.com
SECTION 5 | SEVERITY OF HARM
Select one severity level for the patient or staff member affected. Severity refers to actual harm caused.
Severity of Harm
SECTION 6 | DETAILED DESCRIPTION OF INCIDENT
Detailed Description of Incident
Bonaventure Medical Laboratory Ltd. - Laboratory Professionals, Your Partners for Good Health.
SECTION 7 | IMMEDIATE ACTIONS TAKEN
SECTION 8 | CONTRIBUTING FACTORS
System / Environmental Factors

Inadequate training / competency

Failure to follow SOP Communication breakdown

Fatigue / workload / stress Distraction / interruption Supervision / oversight

SOP unclear, outdated, or missing Equipment malfunction Reagent / supply issue LIS / IT system issue Workspace / environment / lighting Staffing levels / scheduling

Apply the 5-Why technique or fishbone analysis. State the root cause(s) - not the symptoms.
Root Cause Analysis
Bonaventure Medical Laboratory Ltd. - Laboratory Professionals, Your Partners for Good Health.
BONAVENTURE MEDICAL LABORATORY

Quality & Compliance Customer Service: 242-829-8241 | bonaventurelab.com
SECTION 10 | NOTIFICATIONS
Party Notified Ordering Physician / Client

Laboratory Director Quality Manager / COO Safety / Biosafety Officer

Regulatory Body (specify) Other (specify)
SECTION 11 | CORRECTIVE & PREVENTIVE ACTIONS (CAPA)
List actions to correct the immediate issue (corrective) and prevent recurrence (preventive Each item must have an owner and target date. Action RequiredStatus Target Date Responsible

Bonaventure Medical Laboratory Ltd. - Laboratory Professionals, Your Partners for Good Health.
Customer Service: 242-829-8241 | bonaventurelab.com
Reviewer
Date of Follow-Up

MonthDayYear
Date
CAPA actions completed CAPA actions partially completed CAPA actions not completed Effectiveness verified - no recurrence within review period Additional actions required (open new incident or re-open this report)
Effectiveness Review Notes
Date

MonthDayYear
Date
Date

MonthDayYear
Date
Date

MonthDayYear
Date
Date

MonthDayYear
Date
Date Closed

MonthDayYear
Date
Retention: This report shall be retained for a minimum of 5 years (per BML QMS retention policy and CLIA requirements Original filed with Quality Management; copy to involved department.

Bonaventure Medical Laboratory Ltd. - Laboratory Professionals, Your Partners for Good Health.
BONAVENTURE MEDICAL LABORATORY
Quality & Compliance | Customer Service: 242-829-8241 | bonaventurelab.com

Additional Notes / Continuation
Use this page to continue any narrative section document additional witnesses list further corrective or preventive actions or capture any other information not accommodated above Each entry should be dated and initialled
Bonaventure Medical Laboratory Ltd. - Laboratory Professionals, Your Partners for Good Health.
BONAVENTURE MEDICAL LABORATORY
Quality & Compliance | Customer Service: 242-829-8241 | bonaventurelab.com
BML/QM/FRM/GEN/008/V01
Bonaventure Medical Laboratory Ltd. - Laboratory Professionals, Your Partners for Good Health.
Should be Empty:

INCIDENT REPORT FORM

SECTION 5 | SEVERITY OF HARM

SECTION 10 | NOTIFICATIONS

SECTION 11 | CORRECTIVE & PREVENTIVE ACTIONS (CAPA)

BONAVENTURE MEDICAL LABORATORY

BONAVENTURE MEDICAL LABORATORY

BML/QM/FRM/GEN/008/V01