CLIA Regulatory Requirements & Documentation 2

Question 1

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

Accepted Answer

2 years

Answer

1 year

Answer

5 years

Answer

10 years

Question 2

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

Accepted Answer

Certificate of Waiver

Answer

Certificate of Compliance

Answer

Certificate of Registration

Answer

Certificate of Accreditation

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

Monthly

Answer

Semiannually (2 times per year)

Answer

Annually

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

10 days

Answer

45 days

Answer

60 days

Question 5

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

Accepted Answer

Personnel file

Answer

Procedure manual

Answer

Quality control log

Answer

Proficiency testing records

Question 6

Under CLIA regulations, which agency has primary enforcement authority?

Accepted Answer

CMS

Answer

FDA

Answer

CDC

Answer

OSHA

Question 7

What is the CLIA-mandated minimum retention period for patient test records?

Accepted Answer

2 years

Answer

1 year

Answer

5 years

Answer

7 years