– An interdisciplinary team, including supervisors, clinical staff, IT support (if relevant), and the investigator, collaborates to analyze the collected data and identify common patterns. – The team documents key findings, potential contributing factors, and already existing weaknesses in current protocols.
3. Corrective and Preventive Actions • Developing Action Steps:
– Based on the root cause analysis, the investigator, in collaboration with the Quality Assurance Team, develops a set of corrective actions aimed at preventing recurrence. – Each action step includes a clear description, responsible parties, deadlines, and performance indicators to measure effectiveness.
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Communication of Findings:
– The findings and proposed corrective actions are communicated to the involved department heads, the Compliance Liaison, and executive leadership. – Employees implicated in or witnessing the incident receive feedback, and opportunities for additional training or policy adjustment are provided.
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Implementation and Monitoring:
– Corrective actions and preventive measures are implemented immediately or within the predetermined timeframe, depending on severity. – Follow-up reviews and audits are scheduled to ensure that all actions have been effective and that similar incidents do not recur.
4. Documentation and Reporting • Incident Closure:
– Once the investigation is complete and corrective actions have been implemented, the incident is marked as “closed” in the Incident Management System. – A final investigation report is generated, including all relevant documentation and a summary of corrective plans. This report is stored securely in the central records system and is available for internal audits and external regulatory reviews.
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Continuous Learning:
– Lessons learned from the investigation are integrated into training sessions and revisions to standard operating procedures. – The corrective actions, along with their outcomes, are documented and reviewed in subsequent Quality Improvement meetings.
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