CLIA Laboratory Quality Systems & Compliance 4

Question 1

A laboratory performs waived testing only. Which CLIA certificate type does it need?

Accepted Answer

Certificate of Waiver

Answer

Laboratories performing only waived tests must obtain a Certificate of Waiver under CLIA.

Question 2

Under CLIA quality systems, which post-analytic process ensures that critical values reach the ordering provider promptly?

Accepted Answer

Critical value notification

Answer

Critical value notification is a post-analytic requirement to communicate life-threatening results to the responsible clinician without delay.

Question 3

Calibration verification must be performed under CLIA at minimum how often for most quantitative tests?

Accepted Answer

Every 6 months

Answer

CLIA mandates calibration verification at least every 6 months, or whenever certain trigger events occur, for most quantitative tests.

Question 4

A laboratory's QC chart shows a trend of 6 consecutive results progressively moving in one direction without exceeding ±2 SD. This pattern most likely indicates:

Accepted Answer

Systematic error or drift

Answer

A 6-point directional trend on a QC chart signals systematic error or reagent/calibrator drift requiring investigation.

Question 5

Which CLIA-deemed accreditation organization is specifically known for laboratory accreditation in pathology and clinical laboratory science?

Accepted Answer

College of American Pathologists (CAP)

Answer

The College of American Pathologists (CAP) is a CMS-deemed authority widely recognized for laboratory accreditation.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Laboratory Quality Systems & Compliance 4