Laboratory Management Flashcards
7 cards from real ABPATH practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Laboratory Management flashcards as text
Analytical measurement range (AMR) verification confirms:
Answer: The range of values a method can accurately report without dilution or concentration
AMR verification confirms the span of concentrations a method reliably measures directly.
Which safety standard governs bloodborne pathogen exposure control in U.S. labs?
Answer: OSHA Bloodborne Pathogens Standard
The OSHA Bloodborne Pathogens Standard mandates exposure control plans, PPE, and training.
Six Sigma quality at the '6 sigma' level corresponds to approximately how many defects per million opportunities?
Answer: 3.4
Six Sigma performance equates to roughly 3.4 defects per million opportunities.
Method validation for a new FDA-cleared assay used unmodified requires the lab to establish:
Answer: Verification of accuracy, precision, reportable range, and reference intervals
For unmodified FDA-cleared tests, the lab must verify performance characteristics like accuracy, precision, and reference intervals.
The purpose of an inventory par level is to:
Answer: Define the minimum stock that triggers reordering to avoid stockouts
Par level is the minimum inventory that prompts reordering to prevent running out of supplies.
Which of the following best defines analytical specificity?
Answer: The ability of an assay to measure only the intended analyte without interference
Analytical specificity is the assay's ability to measure the target analyte without cross-reacting substances.
A root cause analysis (RCA) is most appropriately performed after:
Answer: A sentinel event or significant laboratory error
RCA is used to systematically investigate the underlying cause of a serious error or sentinel event.