CLIA CLIA Certificate Types & Test Complexity Classifications

Question 1

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

Accepted Answer

Five

Answer

CMS issues five types of CLIA certificates: Certificate of Waiver, Certificate for Provider-Performed Microscopy (PPM), Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation.

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

The Certificate of Waiver covers FDA-approved waived tests that are simple to perform and pose negligible risk of harm to the patient if performed incorrectly.

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

PPM procedures include wet mounts, KOH preparations, pinworm exams, fern tests, and certain urinalysis microscopy performed by a physician, midlevel practitioner, or dentist during the patient encounter.

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

A Certificate of Compliance is issued to laboratories that perform non-waived testing and are subject to inspection by CMS or a CMS-approved state agency.

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

CMS evaluates tests across seven criteria—knowledge, training and experience, reagents and materials, characteristics, troubleshooting and quality control, equipment, and test system—each scored 1 to 3.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA CLIA Certificate Types & Test Complexity Classifications