ABPath Laboratory Management 2 — Questions and Answers
Question 1: Under CLIA, which personnel qualification is required for the laboratory director of a high-complexity testing lab?
- A bachelor's degree in any science
- Board certification in pathology or an MD/DO with appropriate training plus experience (Correct answer)
- A phlebotomy certificate
- Two years of clerical experience
Correct answer: Board certification in pathology or an MD/DO with appropriate training plus experience
CLIA requires a high-complexity lab director to hold an MD/DO (often board-certified in pathology) or a doctoral degree with relevant training and directing experience.
Question 2: The Westgard rule 1-3s is violated when a single control result falls:
- Beyond 1 SD from the mean
- Beyond 2 SD from the mean
- Beyond 3 SD from the mean (Correct answer)
- Exactly at the mean
Correct answer: Beyond 3 SD from the mean
The 1-3s rule flags a run when one control exceeds three standard deviations from the mean.
Question 3: Which metric best describes the fraction of time an analyzer is available and functioning for testing?
- Turnaround time
- Instrument uptime (Correct answer)
- Critical value rate
- Specimen rejection rate
Correct answer: Instrument uptime
Instrument uptime measures the percentage of time equipment is operational and available for use.
Question 4: A proficiency testing (PT) sample must be handled in what manner under CLIA?
- Referred to another lab for confirmation
- Tested in the same manner as patient specimens without inter-lab communication (Correct answer)
- Analyzed only by the director personally
- Repeated until the expected answer is obtained
Correct answer: Tested in the same manner as patient specimens without inter-lab communication
CLIA prohibits referral or communication about PT samples; they must be tested like routine patient specimens.
Question 5: Which of the following is a pre-analytical error?
- Incorrect instrument calibration
- Patient misidentification during collection (Correct answer)
- Transcription error in the report
- Wrong reference range applied
Correct answer: Patient misidentification during collection
Patient misidentification occurs before analysis and is a classic pre-analytical error.
Question 6: The primary purpose of a Levey-Jennings chart is to:
- Track specimen turnaround time
- Monitor quality control values over time to detect shifts and trends (Correct answer)
- Schedule staff shifts
- Calculate reimbursement rates
Correct answer: Monitor quality control values over time to detect shifts and trends
Levey-Jennings charts plot QC values over time to visualize random error, shifts, and trends.
Question 7: A gradual increase in consecutive QC values over several days most likely represents:
- A trend (Correct answer)
- A shift
- Random error
- Normal variation
Correct answer: A trend
A trend is a progressive drift in one direction, often indicating deteriorating reagent or calibration.
ABPath Laboratory Management 2
Under CLIA, which personnel qualification is required for the laboratory director of a high-complexity testing lab?