CLC Risk Assessment & Mitigation 3 — Questions and Answers
Question 1: 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?
- Fishbone diagram retrospective review
- Failure Mode and Effects Analysis (FMEA) (Correct answer)
- Pareto chart analysis of past injuries
- Corrective and Preventive Action (CAPA) log review
Correct answer: Failure Mode and Effects Analysis (FMEA)
FMEA is a prospective method designed to identify potential failure modes and prevent harm before incidents occur.
Question 2: According to ISO 15189, a laboratory's risk management activities should be:
- Conducted only when an accreditation audit is approaching
- Integrated into the quality management system and applied continuously (Correct answer)
- Delegated exclusively to laboratory directors
- Limited to pre-analytical phase processes
Correct 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.
Question 3: A laboratory introduces a new automated analyzer. Which risk-related activity should occur BEFORE go-live?
- Post-implementation review after 90 days of operation
- Retrospective analysis of previous similar analyzer failures industry-wide
- Prospective hazard identification and risk assessment of the new workflow (Correct answer)
- Staff competency assessment for the OLD analyzer being replaced
Correct 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.
Question 4: The Risk Priority Number (RPN) in an FMEA is calculated as:
- Severity + Occurrence + Detectability
- Severity × Occurrence × Detectability (Correct answer)
- Severity × Occurrence ÷ Detectability
- Probability × Impact
Correct answer: Severity × Occurrence × Detectability
RPN = Severity × Occurrence × Detectability; a higher RPN indicates a higher-priority risk for mitigation.
Question 5: A laboratory implements color-coded tube racks to prevent sample mix-ups. This intervention is an example of a:
- Administrative control
- Personal protective equipment (PPE) measure
- Engineering control / mistake-proofing (poka-yoke) (Correct answer)
- Substitution control
Correct 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.
Question 6: Which situation would BEST justify a laboratory's decision to accept a risk rather than control it?
- The risk involves potential patient harm
- The cost of controlling the risk exceeds all available budget for the next five years (Correct answer)
- The risk has been present for more than one year without an incident
- Management is unaware of the risk
Correct 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.
Question 7: A laboratory's fire suppression system malfunctions and damages stored patient specimens. In a risk management review, this event would be classified as a:
- Near-miss with no reportable consequences
- Secondary risk materialized from a control measure (Correct answer)
- Root cause failure requiring immediate staff retraining
- Pre-analytical error in specimen chain of custody
Correct 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.
CLC Risk Assessment & Mitigation 3
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?