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NEW QUESTION # 110
Generally, an incident is defined as:
Answer: A
Explanation:
Broad incident definitions (including near-misses and unsafe conditions) support proactive risk management.
If reporting is limited only to severe harm, the organization loses learning opportunities from early warning signals. Risk management objectives favor capturing deviations from expected process-falls without injury, specimen labeling near-misses, medication dispensing discrepancies-because these events reveal system vulnerabilities that can later cause major harm. Strong incident management includes classification, timely review, escalation thresholds, root cause analysis for significant events, and feedback to frontline staff. This approach aligns with systems-based safety: identify hazards, implement controls, and monitor effectiveness.
NEW QUESTION # 111
Which of the following is a program of the Food and Drug Administration FDA post market surveillance system for medical devices that requires healthcare facilities to report patient deaths or injuries related to a medical device?
Answer: D
Explanation:
Under Health Care Risk Management standards recognized by ASHRM and the American Hospital Association Certification Center, the Safe Medical Devices Act SMDA is part of the FDA's post market surveillance system for medical devices. The SMDA requires healthcare facilities to report to the FDA and, in some cases, to the manufacturer when a medical device has or may have caused or contributed to a patient death or serious injury. This mandatory reporting system enhances device safety monitoring and supports regulatory oversight after products enter the market.
EMTALA governs emergency medical screening and stabilization obligations, not device reporting. The Occupational Safety and Health Act focuses on workplace safety for employees rather than patient device- related injuries. Patient Safety Organizations operate under the Patient Safety and Quality Improvement Act and facilitate voluntary reporting of patient safety events, but they do not replace FDA-mandated device reporting requirements.
Legal and regulatory objectives in healthcare risk management emphasize compliance with federal reporting statutes, timely submission of required reports, and maintenance of documentation to mitigate regulatory exposure. Therefore, the Safe Medical Devices Act is the correct answer regarding mandatory FDA post market surveillance reporting for device-related deaths or injuries.
NEW QUESTION # 112
The source of many medication errors is:
Answer: B
Explanation:
Verbal/telephone orders are widely recognized aserror-pronebecause they can be misheard, misunderstood, or transcribed incorrectly-especially with sound-alike drug names, confusing numerals (15 vs 50), background noise, accents, and interruptions. ISMP and patient safety advisories recommend minimizing verbal orders whenever possible and using safeguards such as read-back/confirm-back, spelling drug names, stating digits individually, and documenting promptly. Risk management objectives include reducing reliance on memory and imperfect communication by prioritizing written or electronic orders (CPOE), standardizing when verbal orders are permitted (true emergencies), and auditing compliance to prevent unsafe normalization. Because medication errors can cause severe harm, controlling verbal order risk is a high-yield safety intervention and improves legal defensibility by aligning practice with recognized safety recommendations.
NEW QUESTION # 113
In a failure mode and effects analysis, the risk priority number is calculated by
Answer: D
Explanation:
According to Health Care Risk Management standards endorsed by ASHRM and the American Hospital Association Certification Center, Failure Mode and Effects Analysis FMEA is a proactive patient safety tool used to identify and prioritize potential process failures before harm occurs. Within FMEA methodology, each potential failure mode is evaluated using three separate scoring components: severity, occurrence, and detection.
Severity measures the potential impact of the failure if it occurs. Occurrence assesses the likelihood that the failure will happen. Detection evaluates the probability that the failure will be identified before causing harm.
Each component is typically assigned a numerical value based on predefined criteria.
The Risk Priority Number RPN is calculated by multiplying the three scores: severity multiplied by occurrence multiplied by detection. This multiplication approach produces a composite score that reflects both the seriousness of potential harm and the likelihood that the event will occur and escape detection. Higher RPN values indicate higher-priority risks requiring mitigation.
Clinical and patient safety objectives emphasize systematic risk prioritization to allocate resources effectively and reduce preventable adverse events. Therefore, the RPN is calculated by multiplying severity, occurrence, and detection scores.
NEW QUESTION # 114
A hospital has opted to open an anticoagulation clinic. As this is a high-risk medication, a risk manager wants to conduct a risk assessment before opening the clinic. The BEST tool to use would be a
Answer: B
Explanation:
Failure Mode and Effects Analysis FMEA is the most appropriate tool in this scenario because it is a proactive risk assessment methodology designed to identify and mitigate potential failures before harm occurs. According to Health Care Risk Management principles outlined by ASHRM and the American Hospital Association Certification Center, FMEA is specifically used when introducing new processes, services, or high-risk clinical operations, such as an anticoagulation clinic involving medications with narrow therapeutic indices and significant bleeding risks.
FMEA systematically evaluates each step in a proposed process, identifies possible failure modes, analyzes their causes and effects, and prioritizes risks using severity, occurrence, and detectability scoring. This structured approach aligns with patient safety objectives by reducing preventable adverse events before implementation.
In contrast, Root Cause Analysis RCA is a retrospective tool used after an adverse event has occurred. A cause and effect diagram is a component often used within RCA or FMEA but is not a comprehensive risk assessment tool on its own. A scatter diagram is primarily used for statistical correlation analysis and does not evaluate process failures.
Therefore, for proactive risk identification and mitigation prior to clinic opening, FMEA is the best and most appropriate tool.
NEW QUESTION # 115
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