Healthcare Incident Investigation SOP

HEALTHCARE INCIDENT INVESTIGATION SOP

Document Control

Document Number:   Effective Date:   Revision:

Facility / Department

Purpose and Scope

Purpose: Establish standardized procedures for timely reporting, investigation, root cause analysis, corrective action, and documentation of incidents affecting patient safety, staff safety, property, or institutional operations.

Scope: This SOP applies to all personnel, contractors, and volunteers at the facility and covers incidents including but not limited to patient falls, medication errors, security breaches, equipment failures, and exposure events.

Definitions

Incident: Any unplanned event resulting in, or with potential for, harm to patients, visitors, staff, property, or operations. Near-miss: An incident that did not reach the patient or cause harm but had the potential to do so.

Responsibilities

Department Managers: Ensure immediate safety actions, notify appropriate leadership, and assign investigation team members. Investigation Lead: Conduct the investigation, document findings, coordinate corrective actions, and submit final report. All Staff: Report incidents immediately in accordance with reporting procedures.

Reporting

Incident Number:

Date of Incident:   Time of Incident:   Location:

Incident Classification

Type of Incident (check all that apply):

Medication error Patient fall Equipment failure Exposure event Security incident

Severity Level: Minor (no harm) Moderate (requires treatment) Major (serious harm) Fatal

Immediate Actions

Actions taken at the scene to secure safety and preserve evidence (stabilize patient, isolate equipment, secure area):

Investigation Team

Investigation Steps

1. Evidence Preservation: Photograph scene, tag equipment, secure records. Document chain of custody for physical evidence.

2. Interviews: List individuals interviewed, dates, and summary of statements.

3. Data Review: Medical records, medication administration, staffing logs, maintenance logs, and surveillance as applicable. Attachments must be referenced in final report.

Corrective and Preventive Actions (CAPA)

For each corrective action, specify description, responsible person, target completion date, and verification method.

Responsible:   Target Completion:   Verification:

Responsible:   Target Completion:   Verification:

Communications and Notifications

Notify involved parties, patient representatives, and regulatory bodies as required by policy. Provide transparent documentation while preserving confidentiality.

Confidentiality and Legal Considerations

All investigation materials are confidential and maintained in secure records. Access is restricted to personnel with a legitimate need to know. Information disclosed in investigations may be subject to legal privilege and local reporting obligations.

Record Retention and Review

Investigation records, supporting documents, and CAPA evidence shall be retained according to facility record retention policy and are subject to audit. Periodic review of action effectiveness shall occur at specified intervals.

Next Review Date:

Training and Dissemination

Results, lessons learned, and corrective actions shall be communicated to relevant staff and incorporated into training. Training records must document participation and competency verification.

Attachments

Attach relevant items (photographs, logs, equipment maintenance records, witness statements). Reference attachments by label and date in the final investigation report.

Certification

By signing below, the approver certifies that the investigation was conducted in accordance with facility policy, findings are accurate to the best of their knowledge, corrective actions are assigned and tracked, and confidentiality has been maintained in accordance with applicable laws and institutional requirements.

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