CLC Laboratory Operations & Quality Management 2

Question 1

A laboratory receives a proficiency testing (PT) sample that yields a Z-score of 3.2. What is the most appropriate immediate action?

Accepted Answer

Investigate potential root causes and implement corrective action before the next PT event

Answer

A Z-score ≥2.0 is considered unsatisfactory and requires root cause investigation and documented corrective action.

Question 2

Which document control practice is required under ISO 15189 to prevent use of obsolete documents?

Accepted Answer

Clearly marking superseded documents and removing them from points of use

Answer

ISO 15189 requires that obsolete documents be promptly removed from all points of use and clearly identified to prevent inadvertent use.

Question 3

A laboratory director reviews QC data and notices a Westgard 10x rule violation. This rule is triggered when:

Accepted Answer

Ten consecutive control values fall on the same side of the mean

Answer

The 10x Westgard rule is violated when 10 consecutive control values fall on the same side of the mean, indicating systematic bias.

Question 4

Under CLIA '88, which of the following tests is classified as high complexity?

Accepted Answer

Gram stain interpretation of a clinical specimen

Answer

Gram stain interpretation requires significant independent judgment and is classified as high complexity under CLIA '88 scoring criteria.

Question 5

A laboratory implements a new centrifuge. Which step is most critical before releasing patient results from this equipment?

Accepted Answer

Completing method verification studies to confirm performance specifications

Answer

Method verification must be completed before any new instrument is placed into service to confirm it meets acceptable performance specifications.

(CLC) Certified Laboratory Consultant Practice Test