Risk Assessment & Mitigation Flashcards
7 cards from real CLC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Assessment & Mitigation flashcards as text
A laboratory is considering outsourcing its send-out testing to three different reference laboratories. From a risk management perspective, this approach primarily addresses which risk?
Answer: Single-vendor dependency risk (concentration risk)
Using multiple reference laboratories reduces concentration risk by ensuring no single vendor failure can disrupt all send-out testing.
The hierarchy of controls for laboratory hazards, ranked from most to least effective, begins with:
Answer: Elimination of the hazard
The hierarchy of controls places elimination at the top as the most effective approach because it removes the hazard entirely rather than managing exposure to it.
A consultant identifies that a laboratory's risk assessments are completed only when a new test is introduced. This practice is DEFICIENT because:
Answer: Risk management should be continuous and responsive to changes in processes, personnel, and technology
Effective risk management requires ongoing reassessment whenever significant changes occur — not only at new test introduction — to keep the risk profile current.
A laboratory receives a vendor notification that reagents from a specific lot may have stability issues. Which risk management step should occur FIRST?
Answer: Quarantine the suspect lot and assess which patient results may be affected
Quarantining the lot and assessing impact on patient results limits further harm and provides the information needed for all subsequent actions.
Which qualitative risk assessment technique uses structured group interviews to systematically question what could go wrong at each step of a laboratory process?
Answer: Hazard and Operability Study (HAZOP)
HAZOP uses guide words applied systematically to each process step during structured group reviews to identify deviations and their consequences.
A laboratory's business continuity plan should include risk mitigation for information technology (IT) failures. Which control BEST ensures laboratory data integrity during an IT outage?
Answer: Maintaining a real-time, geographically separate data backup with tested recovery procedures
A real-time geographically separate backup with tested recovery procedures protects data integrity and minimizes downtime if the primary system fails.
When a laboratory consultant presents risk assessment findings to executive leadership, the information is MOST effectively communicated using:
Answer: A color-coded risk matrix summarizing top risks, owners, and mitigation status
A color-coded risk matrix provides executives with an at-a-glance view of risk severity, ownership, and mitigation progress without overwhelming detail.