CLIA Regulatory Requirements & Documentation 2

Question 1

Under CLIA, how long must laboratories retain quality control records?

Accepted Answer

2 years

Answer

CLIA requires laboratories to retain quality control records for at least 2 years.

Question 2

Which CLIA certificate is required for laboratories that perform only CLIA-waived tests?

Accepted Answer

Certificate of Waiver

Answer

A Certificate of Waiver is issued to laboratories that perform only tests categorized as waived under CLIA.

Question 3

What is the required frequency for proficiency testing (PT) participation under CLIA for most regulated analytes?

Accepted Answer

Quarterly (3 times per year)

Answer

CLIA requires laboratories to participate in proficiency testing at least three times per year for each regulated analyte.

Question 4

A laboratory receives a deficiency citation during a CLIA inspection. Within how many days must a plan of correction be submitted?

Accepted Answer

30 days

Answer

Laboratories must submit a plan of correction to CMS within 10 days of receiving a deficiency citation, though full correction may be allowed 30 days.

Question 5

Which document type serves as the primary record of a laboratory's personnel qualifications under CLIA?

Accepted Answer

Personnel file

Answer

Personnel files document each employee's education, training, competency assessments, and qualifications as required by CLIA.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Regulatory Requirements & Documentation 2