CLIA Regulatory Requirements & Documentation 5

Question 1

Which of the following CLIA sanctions can be imposed on a laboratory found to have condition-level deficiencies?

Accepted Answer

Civil money penalty up to $10,000 per day per violation

Answer

CMS may impose civil money penalties of up to $10,000 per day for each condition-level deficiency identified under CLIA.

Question 2

What is the purpose of the CLIA certificate of registration?

Accepted Answer

Temporary authorization allowing a new laboratory to operate while awaiting inspection

Answer

A Certificate of Registration is a temporary certificate that allows a new laboratory to operate while it undergoes its initial inspection to determine the appropriate certificate level.

Question 3

Under CLIA, which entity is authorized to act as a deemed accreditation organization (AO) in place of CMS inspections?

Accepted Answer

Approved private accrediting organizations such as CAP or The Joint Commission

Answer

CMS-approved accrediting organizations such as CAP and The Joint Commission can survey laboratories in lieu of CMS inspections under CLIA's deemed status program.

Question 4

Which of the following test result documentation elements is explicitly required by CLIA regulations?

Accepted Answer

Identity of the person who performed the test

Answer

CLIA requires documentation of the identity of the person who performed each test as part of the patient test record.

Question 5

A laboratory discovers that it failed a proficiency testing event. Under CLIA, what is the required initial response?

Accepted Answer

Perform an investigation and take corrective action, documenting the findings

Answer

CLIA requires laboratories to investigate the cause of PT failure, implement corrective action, and document all findings — testing may continue during this process.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Regulatory Requirements & Documentation 5