Laboratory Operations & Quality Management Flashcards
7 cards from real CLC 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 Operations & Quality Management flashcards as text
A laboratory receives a proficiency testing (PT) sample that yields a Z-score of 3.2. What is the most appropriate immediate action?
Answer: Investigate potential root causes and implement corrective action before the next PT event
A Z-score ≥2.0 is considered unsatisfactory and requires root cause investigation and documented corrective action.
Which document control practice is required under ISO 15189 to prevent use of obsolete documents?
Answer: Clearly marking superseded documents and removing them from points of use
ISO 15189 requires that obsolete documents be promptly removed from all points of use and clearly identified to prevent inadvertent use.
A laboratory director reviews QC data and notices a Westgard 10x rule violation. This rule is triggered when:
Answer: Ten consecutive control values fall on the same side of the mean
The 10x Westgard rule is violated when 10 consecutive control values fall on the same side of the mean, indicating systematic bias.
Under CLIA '88, which of the following tests is classified as high complexity?
Answer: Gram stain interpretation of a clinical specimen
Gram stain interpretation requires significant independent judgment and is classified as high complexity under CLIA '88 scoring criteria.
A laboratory implements a new centrifuge. Which step is most critical before releasing patient results from this equipment?
Answer: Completing method verification studies to confirm performance specifications
Method verification must be completed before any new instrument is placed into service to confirm it meets acceptable performance specifications.
What is the primary purpose of an internal audit in a clinical laboratory quality management system?
Answer: To evaluate whether the laboratory's processes conform to established requirements
Internal audits systematically evaluate whether the laboratory's processes conform to its own defined requirements and identify opportunities for improvement.
A specimen is received in the laboratory labeled only with a patient room number. According to best practices, what should the laboratory do?
Answer: Reject the specimen and notify the ordering provider for proper recollection
Specimens lacking proper two-identifier patient labeling must be rejected and recollected to prevent patient identification errors.