Healthcare Incident Response Procedures

HEALTHCARE INCIDENT RESPONSE PROCEDURES

Document Information

Effective Date:    Next Review Date:

Purpose

This document establishes the required procedures for identification, reporting, immediate response, investigation, corrective and preventive action, notification and documentation of incidents that affect patient safety, staff safety, facility operations, data privacy, or regulatory compliance. These procedures ensure timely containment, preservation of evidence, assignment of responsibility, mitigation of harm, and prevention of recurrence consistent with applicable law and organizational obligations.

Scope

Applies to all employees, contractors, volunteers, clinical staff, information technology personnel, and third-party service providers at the facility. Incidents subject to these procedures include clinical adverse events, medication errors, patient falls, security incidents, suspected or confirmed protected health information (PHI) breaches, physical plant failures, and other events that may cause harm or regulatory exposure.

Definitions

Adverse Event: an unintended harm to a patient related to medical care rather than the underlying condition. Breach: an impermissible use or disclosure of PHI under applicable privacy law. Containment: actions taken to limit further harm or exposure. Chain of Custody: documented control over physical or electronic evidence from collection through disposition.

Roles and Responsibilities

The facility designates the following primary contacts to execute these procedures, coordinate notifications, and ensure compliance with legal reporting obligations.

Incident Classification

Select the categories that best describe the incident. Multiple selections are permitted.

Medical adverse event    Medication error    Patient fall    Healthcare-associated infection

Physical security incident    Suspected/confirmed PHI breach    Equipment/system failure    Other (specify below)

Immediate Response & Containment

Incident Occurrence Date:   Time:   Location:

Reporting and Notification

All incidents must be reported to the Incident Command/Report System and Risk Management within the following timeframes where applicable: clinical harm or PHI breach — immediate notification; non-critical events — within 24 hours.

Regulatory reporting required: Yes    If yes, specify regulatory bodies and deadlines:

Evidence Preservation & Chain of Custody

Preserve physical and electronic evidence. Do not alter timestamps, delete logs, or change medical records without documented authorization. Maintain a chain of custody log that records each custodian, date/time, actions taken, and storage location.

Investigation and Root Cause Analysis

A timely, objective investigation will be conducted to determine contributing factors and root cause(s). Investigations must document methodology, interviews, data sources, and conclusions. Reports shall not attribute fault without substantiated evidence.

Investigation start date:   Target completion date:

Corrective & Preventive Actions (CAPA)

Document corrective actions intended to remediate root causes and preventive actions to mitigate recurrence. Assign responsibility and acceptable completion dates. Monitor effectiveness.

Action deadline:

Documentation, Retention & Confidentiality

All incident records, investigation reports, chain of custody logs, and notifications shall be maintained in accordance with facility record retention schedules and applicable law. Incident records are confidential and access is restricted to authorized personnel. Alteration or destruction of records to avoid reporting obligations is prohibited and subject to disciplinary action.

Confidentiality maintained: I acknowledge that incident details are confidential and must not be disclosed except as required by law or authorized in writing.

Training & Distribution

Personnel assigned incident response duties must receive training on these procedures. Distribution of this procedure shall be documented and training records retained.

Enforcement

Failure to comply with these procedures, including failure to report incidents or failure to preserve evidence, may result in disciplinary action up to and including termination. Retaliation against individuals who report incidents in good faith is prohibited; allegations of retaliation will be investigated and addressed promptly.

Employee acknowledgment: I acknowledge that I have received, read, and understand these Healthcare Incident Response Procedures and will comply with all reporting and preservation requirements.

Record of Incident (To be completed by Incident Coordinator)

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