Risk Assessment & Mitigation Flashcards

A laboratory consultant reviews a facility where staff routinely bypass the specimen rejection policy because physicians complain about redraws. Which risk management concept does this scenario illustrate?

Answer: Normalization of deviance leading to increased risk

Normalization of deviance occurs when repeated policy violations become accepted practice, gradually eroding safety standards and increasing risk.

During a risk assessment, 'detectability' in the context of FMEA refers to:

Answer: The probability that current controls will identify a failure before it reaches the patient

Detectability scores reflect how likely existing controls are to catch a failure mode before it causes harm; lower detectability scores indicate the failure is easier to detect.

Which of the following laboratory scenarios represents a PROACTIVE risk management approach?

Answer: Conducting a mock tracer audit before regulatory inspection

A mock tracer audit identifies system weaknesses before real inspections or failures occur, making it a proactive (prospective) risk management tool.

A laboratory identifies that a high-volume chemistry analyzer is a single point of failure for stat testing. The BEST risk mitigation response is to:

Answer: Establish a backup analyzer agreement with a reference laboratory

A backup agreement with a reference laboratory maintains continuity for stat testing if the primary analyzer fails, directly addressing the single point of failure risk.

In a clinical laboratory risk register, the 'risk owner' is defined as:

Answer: The person accountable for managing and monitoring a specific risk

A risk owner is the designated individual responsible for monitoring, managing, and reporting on a specific identified risk within the organization.

A laboratory consultant is asked to assess water quality risks in a hospital laboratory. Which water-related risk would be considered HIGHEST priority for patient safety?

Answer: Contaminated water used in clinical grade reagent preparation for patient testing

Contaminated water used in reagent preparation directly affects the accuracy of patient test results, representing an immediate patient safety risk.

Which document is MOST useful for tracking the status of risk mitigation actions over time in a laboratory?

Answer: Risk register with assigned owners and target dates

A risk register is a living document that tracks identified risks, their mitigation plans, assigned owners, target dates, and current status, enabling ongoing management.