CLC Risk Assessment & Mitigation 2 — Questions and Answers
Question 1: A laboratory discovers that a centrifuge has a 15% probability of catastrophic failure per year and that such a failure would cause $200,000 in damages. What is the annualized loss expectancy (ALE)?
- $30,000 (Correct answer)
- $15,000
- $200,000
- $215,000
Correct answer: $30,000
ALE = Single Loss Expectancy × Annual Rate of Occurrence = $200,000 × 0.15 = $30,000.
Question 2: Which risk mitigation strategy involves purchasing insurance to cover potential laboratory losses?
- Risk avoidance
- Risk acceptance
- Risk transfer (Correct answer)
- Risk reduction
Correct answer: Risk transfer
Risk transfer shifts the financial burden of a risk to a third party, such as an insurer.
Question 3: A Failure Mode and Effects Analysis (FMEA) in a clinical laboratory primarily helps to:
- Satisfy accreditation documentation requirements
- Proactively identify process steps most likely to fail and their impact (Correct answer)
- Calculate the financial cost of equipment downtime
- Assign disciplinary actions to staff who cause errors
Correct answer: Proactively identify process steps most likely to fail and their impact
FMEA is a prospective tool that identifies potential failure modes, their causes, and their effects on patient safety or workflow before they occur.
Question 4: In a risk matrix, a hazard rated HIGH likelihood and LOW severity is typically categorized as:
- Critical risk requiring immediate action
- Acceptable risk with no controls needed
- Moderate risk requiring monitoring and controls (Correct answer)
- Negligible risk to be logged only
Correct answer: Moderate risk requiring monitoring and controls
High likelihood combined with low severity places a hazard in a moderate risk zone, warranting controls and ongoing monitoring.
Question 5: When conducting a root cause analysis (RCA) after a laboratory near-miss, the MOST important first step is to:
- Retrain the staff member involved
- Secure and preserve all relevant evidence and records (Correct answer)
- Notify the laboratory's insurance carrier
- Implement corrective action immediately
Correct answer: Secure and preserve all relevant evidence and records
Preserving evidence ensures the RCA has accurate information to identify the true root cause before any changes are made.
Question 6: A laboratory consultant recommends implementing redundant freezer alarms connected to an off-site monitoring service. This action exemplifies which risk control strategy?
- Risk avoidance
- Risk elimination
- Risk reduction through engineering controls (Correct answer)
- Risk acceptance
Correct answer: Risk reduction through engineering controls
Redundant alarms with off-site monitoring are engineering controls that reduce the likelihood and impact of sample loss from freezer failure.
Question 7: Which of the following best describes residual risk in a laboratory context?
- Risk that has been fully eliminated through corrective action
- Risk remaining after all planned controls have been implemented (Correct answer)
- Risk identified during an initial hazard survey before any assessment
- Risk transferred to a third-party vendor
Correct answer: Risk remaining after all planned controls have been implemented
Residual risk is the level of risk that persists after controls are applied; it must still be evaluated for acceptability.
CLC Risk Assessment & Mitigation 2
A laboratory discovers that a centrifuge has a 15% probability of catastrophic failure per year and that such a failure would cause $200,000 in damages.
What is the annualized loss expectancy (ALE)?