CLIA CLIA Certificate Types & Test Complexity Classifications 1 — Questions and Answers
Question 1: How many distinct types of CLIA certificates can a laboratory obtain from CMS?
- Three
- Four
- Five (Correct answer)
- Six
Correct answer: Five
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?
- Certificate of Compliance
- Certificate of Registration
- Certificate of Waiver (Correct answer)
- Certificate of Accreditation
Correct answer: Certificate of Waiver
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)?
- Automated cell differential counts
- Wet mounts, KOH preparations, and fern tests performed during the patient visit (Correct answer)
- Gram stains sent to a reference lab
- Acid-fast bacilli smears
Correct answer: Wet mounts, KOH preparations, and fern tests performed during the patient visit
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?
- Certificate of Registration
- Certificate of Accreditation
- Certificate of Waiver
- Certificate of Compliance (Correct answer)
Correct answer: Certificate of Compliance
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?
- Five
- Six
- Seven (Correct answer)
- Ten
Correct answer: Seven
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.
Question 6: Laboratories holding only a Certificate of Waiver are subject to which type of CMS inspection?
- Biennial routine inspections
- Annual announced inspections
- Complaint inspections only (Correct answer)
- Inspections every six months
Correct answer: Complaint inspections only
Certificate of Waiver laboratories are exempt from routine CLIA inspections and are only subject to complaint investigations or inspections for cause.
Question 7: Which of the following tests is most likely classified as a CLIA-waived test?
- Manual white blood cell differential
- Urine culture and sensitivity
- FDA-cleared home-use blood glucose monitor used in a physician office (Correct answer)
- Prothrombin time by manual tilt tube method
Correct answer: FDA-cleared home-use blood glucose monitor used in a physician office
FDA-cleared home-use blood glucose monitors that have been granted waived status are examples of waived tests under CLIA when used in a point-of-care setting.
CLIA CLIA Certificate Types & Test Complexity Classifications 1
How many distinct types of CLIA certificates can a laboratory obtain from CMS?