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's biosafety officer wants to evaluate the risk of needle-stick injuries from phlebotomy staff. Which tool is MOST appropriate for this prospective risk assessment?
Answer: Failure Mode and Effects Analysis (FMEA)
FMEA is a prospective method designed to identify potential failure modes and prevent harm before incidents occur.
According to ISO 15189, a laboratory's risk management activities should be:
Answer: Integrated into the quality management system and applied continuously
ISO 15189 requires risk management to be ongoing and embedded within the overall quality management system, not limited to specific phases or events.
A laboratory introduces a new automated analyzer. Which risk-related activity should occur BEFORE go-live?
Answer: Prospective hazard identification and risk assessment of the new workflow
A prospective hazard identification and risk assessment of the new analyzer workflow should be completed before implementation to identify and mitigate risks in advance.
The Risk Priority Number (RPN) in an FMEA is calculated as:
Answer: Severity × Occurrence × Detectability
RPN = Severity × Occurrence × Detectability; a higher RPN indicates a higher-priority risk for mitigation.
A laboratory implements color-coded tube racks to prevent sample mix-ups. This intervention is an example of a:
Answer: Engineering control / mistake-proofing (poka-yoke)
Color-coded racks are an engineering/mistake-proofing control that makes errors immediately visible without relying on staff memory or procedure adherence.
Which situation would BEST justify a laboratory's decision to accept a risk rather than control it?
Answer: The cost of controlling the risk exceeds all available budget for the next five years
Risk acceptance may be justified when the cost of mitigation significantly outweighs the expected benefit, provided the residual risk is within acceptable limits and documented.
A laboratory's fire suppression system malfunctions and damages stored patient specimens. In a risk management review, this event would be classified as a:
Answer: Secondary risk materialized from a control measure
When a control measure (the suppression system) itself causes harm, the resulting loss is a secondary or emergent risk arising from the mitigation itself.