CLC Professional Standards & Competencies 3

Question 1

Which CLIA certificate level is required for laboratories performing tests classified as 'high complexity'?

Accepted Answer

Certificate of Compliance

Answer

A Certificate of Compliance (or Accreditation) is required for laboratories performing high-complexity testing under CLIA regulations.

Question 2

A consultant recommends a laboratory implement a delta check system. The primary purpose of this quality tool is to:

Accepted Answer

Flag patient results that differ significantly from previous values

Answer

Delta checks compare a patient's current result with their previous result to detect potential specimen mix-ups or clinically significant changes.

Question 3

Competency assessment for laboratory testing personnel must be performed:

Accepted Answer

At initial hire and semiannually for the first year, then annually

Answer

CLIA requires competency assessment for high-complexity testing personnel at 6 months and 12 months during the first year, then at least annually thereafter.

Question 4

Which of the following is NOT one of the six CLIA-mandated competency assessment elements?

Accepted Answer

Evaluation of interpersonal communication skills

Answer

The six CLIA competency elements focus on technical and procedural skills; interpersonal communication is not among the mandated elements.

Question 5

When a laboratory introduces a new quantitative test, the minimum number of samples typically required to establish analytical measurement range (AMR) is:

Accepted Answer

20

Answer

Clinical laboratory guidelines (e.g., CLSI EP06) recommend a minimum of approximately 20 samples spanning the reportable range to establish AMR.

(CLC) Certified Laboratory Consultant Practice Test

(CLC) Certified Laboratory Consultant Practice Test

CLC Professional Standards & Competencies 3