Implementing a new device, especially for high-risk procedures like chemotherapy, requires proactive risk assessment to prevent potential errors.

Option A (Cause and effect diagram): Also known as a fishbone diagram, this identifies causes of existing problems, not potential risks of a new device.

Option B (Failure mode and effects analysis (FMEA)): This is the correct answer. The NAHQ CPHQ study guide states, “FMEA is a proactive tool used to identify potential failure modes, their effects, and mitigation strategies before implementing new processes or devices” (Domain 1). For a chemotherapy device, FMEA assesses risks like dosing errors or device malfunctions.

Option C (Common cause analysis): This analyzes routine variations, not specific risks of new devices.

Option D (Root cause analysis (RCA)): RCA is reactive, used after an incident, not proactively before implementation.

CPHQ Objective Reference: Domain 1: Patient Safety, Objective 1.5, “Use proactive risk assessment tools,” emphasizes FMEA for new processes. The NAHQ study guide notes, “FMEA is critical for identifying risks in high-stakes interventions like chemotherapy” (Domain 1).

Rationale: FMEA proactively identifies and mitigates risks for a new chemotherapy device, aligning with CPHQ’s patient safety principles.