Adverse Event Management and Reporting Policy

1. Policy Statement

It is the policy of this organization that all adverse events, serious adverse events (including sentinel events), and close calls associated with infusion therapy or vascular access devices shall be comprehensively documented within the patient health record, reported through organizational reporting systems, and communicated to appropriate regulatory bodies when required. The organization shall maintain a prevention-focused culture grounded in just culture principles, interprofessional investigation, and transparent disclosure to patients, families, and staff at all levels.

2. Purpose

This policy exists to:

• Establish robust, standardized systems for identifying, documenting, and tracking adverse events related to infusion therapy and vascular access devices.
• Define internal and external reporting pathways and timeframes for all categories of adverse events.
• Mandate formal root cause analysis (RCA) for serious adverse events and sentinel events, with aggregate trend analysis across clusters of events.
• Build and sustain a just culture that encourages clinician reporting without fear of retribution, focusing on system correction rather than individual blame.
• Ensure responsible, timely disclosure of errors to patients and families.
• Protect the wellbeing of healthcare workers who experience psychological trauma following adverse events (“second victims”).

3. Scope

This policy applies to:

• All clinical and non-clinical personnel who participate in the delivery, management, or support of infusion therapy and vascular access care.
• All adverse events, serious adverse events, sentinel events, and near-miss incidents associated with vascular access devices or infusion therapy in any care setting.
• Organizational leadership, Quality and Patient Safety, Risk Management, Infection Prevention, Clinical Education, and all departments supporting vascular access services.
• All care settings, including inpatient, ambulatory, home care, and long-term care.

4. Policy Requirements

4.1 Foundational Principles

4.1.1 Comprehensive Documentation. All adverse events, serious adverse events, sentinel events, and close calls shall be documented objectively and factually in the patient’s health record and reported through the organization’s electronic safety reporting system. Documentation shall be fact-based, avoiding subjective interpretation or speculation.

4.1.2 Patient and Caregiver Education. Clinical staff shall educate patients and caregivers about signs, symptoms, and warning indicators of complications or adverse reactions. Patients shall receive clear instructions on how to contact appropriate clinicians—whether home care nurses, ambulatory staff, or emergency services—when concerning symptoms arise.

4.1.3 Staffing and Safety. Organizations shall maintain adequate staffing levels and appropriate skill mixes to support safe care delivery. Evidence consistently demonstrates that fewer adverse events occur when organizations maintain appropriate staffing ratios and support ongoing competency development.

4.2 Internal Reporting Pathways

4.2.1 Adverse events and close calls must be reported through the organization’s electronic safety reporting system within the timeframes established by organizational policy. At minimum, the following stakeholders shall be notified:

• The patient’s attending provider and essential healthcare team members.
• Organizational management personnel with relevant oversight responsibility.
• Risk Management and Quality Improvement departments.
• Infection Prevention when the event involves or may involve infectious exposure.

4.2.2 Events meeting criteria for sentinel event designation shall be reported to the Chief Nursing Officer, Chief Medical Officer, and organizational executive leadership within twenty-four (24) hours of discovery.

4.3 External Reporting Requirements

4.3.1 Organizations shall report to applicable external entities in accordance with regulatory and accreditation requirements, including:

• Regulatory bodies: The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database for device-related events; applicable international agencies (Health Canada, BfArM, MHRA, Swissmedic, Anvisa) as relevant to the organization’s operating jurisdiction.
• Advisory organizations: Institute for Safe Medication Practices (ISMP) for medication-related events.
• Accreditation organizations: The Joint Commission, Joint Commission International, Healthcare Facilities Accreditation Program, Det Norske Veritas, Community Health Accreditation Partner, and Accreditation Commission for Health Care, in accordance with institutional policy and accreditation standards.

4.3.2 When a product defect contributes to an adverse event, the defective device shall be retained and returned to the manufacturer as part of the product incident report to enable thorough failure mode investigation.

4.4 Investigation and Root Cause Analysis

4.4.1 RCA Criteria. The organization shall maintain clear processes for determining which serious adverse events require formal root cause analysis. At minimum, RCA is required for all sentinel events, events involving death or serious physical harm, and clusters of two or more similar adverse events within a defined timeframe.

4.4.2 RCA Methodology. Root cause analysis shall employ a systematic, interprofessional process to determine not only what happened, but why—examining environmental factors, system issues, human factors, equipment performance, and process vulnerabilities at the individual, team, system, and environmental levels. The RCA shall produce a corrective action plan with defined responsible parties and completion timelines.

4.4.3 Aggregate Analysis. The organization shall analyze adverse events in aggregate on a regular basis to identify organization-specific trends affecting multiple incidents. Aggregate analysis reveals patterns that single-event investigation may miss and enables systemic improvement interventions.

4.4.4 Interprofessional Approach. Clinical staff shall actively participate in the development, implementation, and evaluation of improvement plans arising from investigations. Improvement plans shall address eight domains of patient safety: transformational leadership, patient engagement, human resources management quality, innovation technology, skill competency, education in patient safety, teamwork, and effective communication.

4.5 Building a Culture of Safety

4.5.1 Just Culture. The organization shall maintain a just culture that focuses on correcting systems and processes rather than blaming individual clinicians. The just culture framework shall distinguish between: human error (which requires system improvement and supportive coaching), at-risk behavior (which requires coaching to make safer choices), and reckless behavior (which may require disciplinary action). A validated algorithm (e.g., the Just Culture Algorithm™) shall guide this assessment.

4.5.2 Non-Retaliation. No clinician shall face adverse employment action, harassment, or retaliation for reporting a safety concern, error, or near-miss in good faith. Retaliation against a reporter is itself a policy violation subject to disciplinary action.

4.5.3 Teamwork and Communication. The organization shall advocate for and implement teamwork interventions including: training and education focused on communication and leadership, interprofessional rounds and team huddles, structured handoff communication tools and checklists, and sustained management support for safety initiatives.

4.5.4 Proactive Safety Methods. Healthcare Failure Mode and Effect Analysis (HFMEA) shall be used as a proactive tool to identify potential failure modes before adverse events occur. HFMEA shall be conducted when new procedures are introduced, significant process changes are implemented, or high-risk processes are redesigned.

4.5.5 Simplified Reporting. The organization shall standardize and simplify adverse event reporting processes to reduce barriers to reporting. Clinical staff shall include patient safety discussions in rounds to identify and report adverse events promptly.

4.6 Transparency and Disclosure

4.6.1 The organization shall maintain a culture of safety transparency that encourages reporting and empowers clinicians to identify and implement appropriate actions to prevent adverse events.

4.6.2 Error Disclosure. Healthcare teams shall ensure responsible, timely disclosure of errors to patients, caregivers, or surrogates. Disclosure discussions shall be planned interprofessionally and, where appropriate, patients, caregivers, or surrogates shall be included in adverse event review.

4.6.3 Communication of Lessons Learned. The organization shall communicate necessary practice changes to staff at all levels in a clear, consistent manner reinforced through multiple channels. Lessons learned shall translate into sustained improvements across the organization.

4.7 Second Victim Support

4.7.1 The organization recognizes that clinicians who are involved in adverse patient events may experience significant psychological distress, including anxiety, depression, reduced professional confidence, and post-traumatic stress. These individuals are referred to as “second victims.”

4.7.2 The organization shall implement formal support programs for second victims, including access to peer support networks, professional counseling services, and structured resources for emotional recovery. This support is available without stigma or career penalty.

5. Compliance

5.1 Monitoring. Compliance shall be monitored through review of safety event reporting volume and trends (higher volume indicates healthier reporting culture), RCA completion rates and corrective action implementation timelines, external regulatory reporting compliance, and annual just culture staff surveys measuring perception of reporting safety.

5.2 Key Performance Indicators.

• Safety event reporting rate (target: year-over-year increase indicating cultural improvement).
• RCA completion rate within defined timelines for qualifying events (target: 100%).
• External reporting compliance rate for events meeting regulatory thresholds (target: 100%).
• Second victim support program utilization and satisfaction rates.

5.3 Enforcement. Failure to report a known adverse event or sentinel event is a serious policy violation. Failure of leadership to conduct required RCAs or implement corrective actions shall be escalated to the Chief Nursing Officer and Chief Medical Officer.

6. Exceptions

6.1 Documentation of an adverse event may be briefly deferred (no longer than two hours) when the patient’s clinical condition requires continuous, uninterrupted care. All required documentation shall be completed as soon as the patient is stabilized.

6.2 External reporting timeframes are governed by applicable regulatory requirements, which supersede internal policy. No internal exception shall be granted that delays a legally mandated external report.

7. Related Documents

• POL-008: Quality Improvement in Vascular Access
• POL-003: Evidence-Based Selection and Clinical Monitoring Standards
• POL-012: Documentation in the Health Record for Vascular Access
• SOP-VA-080: Vascular Access Root Cause Analysis Procedure
• SOP-VA-081: HFMEA Procedure for Vascular Access Processes
• Organizational Safety Event Reporting Policy
• Organizational Just Culture Policy
• Organizational Disclosure of Unanticipated Outcomes Policy
• FDA MedWatch Program
• FDA MAUDE Database Reporting Requirements
• ISMP Medication Error Reporting Program
• Joint Commission Sentinel Event Policy and Procedures
• NHSN Surveillance Protocols

8. Revision History