CLC CLC Laboratory Accreditation & Certification Processes 1

Question 1

Which federal law primarily governs clinical laboratory testing in the United States and requires laboratories to meet specific quality standards?

Accepted Answer

CLIA (Clinical Laboratory Improvement Amendments)

Answer

CLIA (Clinical Laboratory Improvement Amendments of 1988) is the federal law that regulates all clinical laboratory testing performed on humans in the US.

Question 2

Which accrediting organization offers the most widely recognized laboratory accreditation program and is deemed by CMS to meet CLIA requirements?

Accepted Answer

College of American Pathologists (CAP)

Answer

The College of American Pathologists (CAP) accreditation program is broadly recognized and is CMS-deemed, meaning CAP-accredited labs are considered to meet CLIA standards.

Question 3

Under CLIA, which test category requires the least regulatory oversight because it poses the lowest risk for patient harm if performed incorrectly?

Accepted Answer

Waived tests

Answer

Waived tests are cleared by the FDA for home use or are simple, accurate tests with low risk for error, and require only a CLIA certificate of waiver.

Question 4

A laboratory consultant is reviewing accreditation survey findings. Which type of CAP deficiency requires an immediate corrective action plan submitted within 30 days?

Accepted Answer

Phase II deficiency

Answer

CAP Phase II deficiencies represent significant non-compliance and require a corrective action plan submitted within 30 days of the survey report.

Question 5

Which document outlines the specific standards a laboratory must meet during a CAP accreditation inspection?

Accepted Answer

CAP Checklists

Answer

CAP Checklists are the inspection documents used during accreditation surveys to assess compliance with specific standards across all laboratory sections.

(CLC) Certified Laboratory Consultant Practice Test

(CLC) Certified Laboratory Consultant Practice Test

CLC CLC Laboratory Accreditation & Certification Processes 1