CLC CLC Laboratory Accreditation & Certification Processes

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

HIPAA

Answer

OSHA Act

Answer

FDA Safety Act

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 Joint Commission (TJC)

Answer

AAAHC

Answer

DNV GL Healthcare

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

Moderate complexity

Answer

High complexity

Answer

Provider-performed microscopy

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

Phase I deficiency

Answer

Observation

Answer

Best practice recommendation

Question 5

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

Accepted Answer

CAP Checklists

Answer

Laboratory policy manual

Answer

CLIA certificate application

Answer

Laboratory director's CV

Question 6

A laboratory pursuing ISO 15189 accreditation is primarily demonstrating competence in which area?

Accepted Answer

Medical laboratory quality and competence

Answer

Environmental health and safety

Answer

Pharmaceutical manufacturing

Answer

Hospital administration