Do I Need CLIA Certification?

What are the different types of CLIA certificates?

Certificate of Waiver.Certificate for Provider-Performed Microscopy Procedures (PPMP)Certificate of Registration.Certificate of Compliance.Certificate of Accreditation..

How long does it take to get CLIA certification?

between 4-12 weeksDepending on your state health department, it can take between 4-12 weeks to receive your CLIA certificate. The CLIA certificate of waiver is necessary for state and federal compliance, and provides the benefit of facilitating provider reimburse- ment for the use of CLIA-waived tests.

How do I get CLIA certified?

To receive a CLIA certification, a laboratory must apply using the CLIA application (Form CMS- 116). This form collects information about your laboratory operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA.

What is CLIA certificate?

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

Who needs CLIA certification?

CLIA certification is required for facilities that test clinical specimens for the purpose of diagnosis, treatment, or prevention of disease. If your facility only collects specimens to be sent out for testing at another facility, then CLIA certification is not required for your facility.

What are the 3 levels of CLIA testing?

The basis of the complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity.

How do I check my CLIA status?

You may verify your CLIA certification level and effective dates at: https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information.

Do you need a CLIA license to draw blood?

Q: If I’m only doing blood draws, do I need a CLIA number? A: No. You do not require a CLIA number if the facility only collects specimens and performs no testing.

What does CLIA mean?

Clinical Laboratory Improvement Amendments (CLIA) CLIA Law & Regulations.