CLIA CLIA Certificate Types & Test Complexity Classifications 1

Question 1

How many distinct types of CLIA certificates can a laboratory obtain from CMS?

Accepted Answer

Five

Answer

Three

Answer

Four

Answer

Six

Question 2

Which CLIA certificate is designed for laboratories that perform only simple tests with a low risk of erroneous results?

Accepted Answer

Certificate of Waiver

Answer

Certificate of Compliance

Answer

Certificate of Registration

Answer

Certificate of Accreditation

Question 3

Under CLIA, which type of microscopy procedures qualify for a Certificate for Provider-Performed Microscopy (PPM)?

Accepted Answer

Wet mounts, KOH preparations, and fern tests performed during the patient visit

Answer

Automated cell differential counts

Answer

Gram stains sent to a reference lab

Answer

Acid-fast bacilli smears

Question 4

A laboratory performing moderate- or high-complexity testing that is inspected directly by CMS or a state agency holds which certificate?

Accepted Answer

Certificate of Compliance

Answer

Certificate of Registration

Answer

Certificate of Accreditation

Answer

Certificate of Waiver

Question 5

CMS uses a scoring system based on how many criteria to categorize laboratory tests as waived, moderate-, or high-complexity?

Accepted Answer

Seven

Answer

Five

Answer

Six

Answer

Ten

Question 6

Laboratories holding only a Certificate of Waiver are subject to which type of CMS inspection?

Accepted Answer

Complaint inspections only

Answer

Biennial routine inspections

Answer

Annual announced inspections

Answer

Inspections every six months

Question 7

Which of the following tests is most likely classified as a CLIA-waived test?

Accepted Answer

FDA-cleared home-use blood glucose monitor used in a physician office

Answer

Manual white blood cell differential

Answer

Urine culture and sensitivity

Answer

Prothrombin time by manual tilt tube method