Proactive evaluation of clinical risk: a FMECA analysis in pediatric chemotherapy

Area of Science:

• Pediatric Oncology
• Health Risk Management
• Patient Safety

Background:

• Chemotherapy medication management in pediatric cancer patients presents significant risks.
• Traditional paper-based systems are prone to errors, impacting patient safety.
• A systematic risk assessment is crucial for identifying and mitigating these vulnerabilities.

Purpose of the Study:

• To prospectively assess risk management in pediatric cancer chemotherapy using Failure Mode, Effects, and Criticality Analysis (FMECA).
• To identify critical failure points and their underlying causes in the chemotherapy medication process.
• To propose risk-reducing actions based on the assessment findings.

Main Methods:

• Failure Mode, Effects, and Criticality Analysis (FMECA) was employed.
• A flowchart of the chemotherapy process was developed to map potential failure points.
• Risk Priority Numbers (RPN) were calculated based on severity, occurrence, and detection likelihood.
• A web-based tool supported FMECA activities.

Main Results:

• The highest RPN values were associated with paper-based chemotherapy medication orders from clinicians to Pharmacy.
• Transcription of orders into pharmacy worksheets and medication selection for preparation also showed high RPNs.
• Illegible or incomplete handwriting was identified as a primary cause of these failures.

Conclusions:

• Paper-based systems for pediatric chemotherapy present significant risks, particularly in order transmission and preparation.
• Illegible handwriting is a major contributing factor to medication errors.
• Transitioning to an electronic ordering process is recommended to mitigate identified risks and enhance patient safety.