Quality Control & Assurance in Laboratory Practices Flashcards
7 cards from real CMLA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Control & Assurance in Laboratory Practices flashcards as text
Which concept describes the maximum allowable difference between a test result and the true value, combining both systematic and random error?
Answer: Total allowable error (TEa)
Total allowable error (TEa) defines the maximum acceptable combination of bias and imprecision, used as the quality goal for a laboratory method.
A laboratory receives a proficiency testing challenge with five specimens. Under CLIA, how many must be reported to avoid a potential PT failure?
Answer: At least three of five (60%)
CLIA requires at least 80% satisfactory results on a PT challenge, but since graded on a score basis, typically 4/5 or 3/5 passing meets requirements depending on analyte-specific criteria.
What is the correct interpretation when a Levey-Jennings chart shows control values scattered randomly above and below the mean with large variability?
Answer: The method has a random error problem
Wide, random scatter of control values above and below the mean indicates random error, often caused by pipetting inconsistencies, temperature fluctuations, or unstable reagents.
Which corrective action is most appropriate when a single control value fails the 1-3s rejection rule?
Answer: Stop patient testing, investigate the cause, and repeat QC before reporting results
A 1-3s violation is a rejection rule requiring the laboratory to stop reporting, identify the root cause, resolve the issue, and confirm QC is acceptable before continuing.
Which of the following is NOT a component of a laboratory quality assurance (QA) program?
Answer: Patient result billing accuracy
Billing accuracy is a compliance and revenue cycle function, not a component of the laboratory quality assurance program focused on analytical and clinical quality.
When establishing a new QC mean and standard deviation for a control material, the minimum number of data points typically recommended is:
Answer: 20 data points over 20 days
At least 20 data points collected over 20 days is the standard recommendation to establish a reliable mean and standard deviation for QC materials.
A delta check compares a patient's current laboratory result to their previous result. Its primary purpose is to:
Answer: Detect specimen identification or pre-analytical errors
Delta checks flag unexpectedly large changes between sequential patient results, most commonly caused by wrong-patient specimens or sample misidentification.