AACC AACC Laboratory Management & Operations 2 — Questions and Answers
Question 1: Which of the following best describes a 'delta check' in laboratory quality management?
- A comparison of results between two different analyzers
- A comparison of a patient's current result with their previous result to flag unusual changes (Correct answer)
- A daily comparison of QC data against Westgard rules
- A review of reagent lot changes
Correct answer: A comparison of a patient's current result with their previous result to flag unusual changes
Delta checks compare a patient's current result to prior results to identify clinically implausible changes that may indicate specimen labeling or collection errors.
Question 2: A laboratory is evaluating a new glucose analyzer. Which statistical measure is used to assess the agreement between the new method and the reference method?
- Coefficient of variation (CV)
- Passing-Bablok regression (Correct answer)
- Levey-Jennings chart
- Youden plot
Correct answer: Passing-Bablok regression
Passing-Bablok regression is a non-parametric statistical method used during method comparison to assess systematic and proportional bias between two methods.
Question 3: What is the purpose of a proficiency testing (PT) program in a clinical laboratory?
- To train new laboratory staff on test procedures
- To assess a laboratory's performance by testing unknown samples alongside peer laboratories (Correct answer)
- To validate new reagent lots before use
- To monitor equipment preventive maintenance schedules
Correct answer: To assess a laboratory's performance by testing unknown samples alongside peer laboratories
PT programs send unknown samples to laboratories so that results can be compared against peers, serving as an external quality assessment tool required by CLIA.
Question 4: According to OSHA Bloodborne Pathogens Standard, which type of container must be used to dispose of sharps in a clinical laboratory?
- Biohazard bag
- Puncture-resistant sharps container (Correct answer)
- Standard waste basket with lid
- Autoclave bag
Correct answer: Puncture-resistant sharps container
OSHA requires that contaminated sharps be placed immediately in puncture-resistant, leak-proof, labeled sharps containers to prevent needlestick injuries.
Question 5: Which laboratory management principle involves tracking supplies from receipt to use and disposal to prevent stockouts and reduce waste?
- Lean methodology
- Inventory management (Correct answer)
- Six Sigma
- Root cause analysis
Correct answer: Inventory management
Inventory management ensures adequate supply availability, controls costs, and prevents expiration of reagents and consumables in the laboratory.
Question 6: What is the role of the laboratory medical director in a CLIA-certified laboratory?
- Performing all laboratory testing personally
- Providing overall oversight of laboratory operations and ensuring quality and accuracy of testing (Correct answer)
- Managing billing and insurance reimbursement
- Handling all specimen collection from patients
Correct answer: Providing overall oversight of laboratory operations and ensuring quality and accuracy of testing
The laboratory medical director is responsible for overall laboratory management, test result integrity, staff qualifications, and compliance with regulatory requirements.
AACC AACC Laboratory Management & Operations 2
Which of the following best describes a 'delta check' in laboratory quality management?