Quality control and quality assurance concepts, laboratory safety, and specimen handling procedures for clinical laboratories.
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- What is the purpose of internal quality control (QC) materials in the lab?
- To monitor the accuracy and precision of test results before releasing patient results
- What are Westgard rules used for?
- Statistical rules to evaluate whether quality control results are within acceptable limits
- What does the 1-2s Westgard rule indicate?
- A warning rule, when one control result exceeds two standard deviations, prompting a closer look but not necessarily rejection
- What does the 1-3s Westgard rule indicate?
- A rejection rule, when one control result exceeds three standard deviations from the mean
- What is a Levey-Jennings chart used for?
- Graphically plotting quality control values over time to detect trends and shifts
- What is the difference between accuracy and precision in laboratory testing?
- Accuracy is how close a result is to the true value, while precision is how reproducible repeated results are
- What is a shift on a Levey-Jennings chart?
- A sudden and sustained movement of QC values to a new level, indicating a systematic change
- What is a trend on a Levey-Jennings chart?
- A gradual, continuous movement of QC values in one direction over several runs
- What does proficiency testing (PT) evaluate?
- A laboratory's ability to accurately test unknown samples compared to peer laboratories
- What agency regulates clinical laboratory testing quality in the United States?
- CLIA (Clinical Laboratory Improvement Amendments)
- What are the three CLIA complexity categories for laboratory tests?
- Waived, moderate complexity, and high complexity
- What organization commonly provides voluntary laboratory accreditation, such as for hospital labs?
- College of American Pathologists (CAP)
- What is a standard operating procedure (SOP) in a laboratory?
- A written, detailed set of instructions for performing a specific laboratory procedure consistently
- What is the purpose of calibration in laboratory instrumentation?
- To establish the relationship between instrument response and known analyte concentrations for accurate results
- What is a delta check used for in laboratory quality?
- Comparing a patient's current result to their previous result to flag unexpected changes that may indicate error