Obtaining a CLIA certification is a simple and straightforward task

CLIA stands for Clinical Laboratory Improvement Amendments of 1988. This is a federal law that requires a certificate for any facility that collects human samples and performs tests for the purpose of diagnosis, treatment, or prevention. Even performing one test, including those that are waived, will require the facility to be certified. Here is how to get a CLIA Waived Certificate and CLIA certified.

How to Get clia Waived Certificate

First, you will need to submit Form CMS-116 to your local state agency that oversees CLIA certification where your facility is located. The application is available online. If you have multiple facilities, you must submit Form CMS-116 for each one individually. After the agency has received your application, they will mail you a coupon that states what your fee is. After you send in your payment, the agency will then send you the CLIA Certificate.

It can take anywhere between four and 12 weeks to get your CLIA certificate, depending on your local agency.

In most cases, you will be able to start testing after you receive your certificate. However, it is important to check with your local agency first. Some states have additional requirements that must be met before you can start testing.

There are five different certification options. The type you apply for will depend on what type of testing your facility will be doing.

• Certificate of Waiver (COW): Used only by facilities that perform waived tests.
• Certificate for Provider-Performed Microscopy (PPM) Procedures: Testing that includes microscopy during patient visits.
• Certificate of Registration: Allows facilities to perform non-waived tests until the lab is inspected and determined to be in compliance with CLIA regulations.
• Certificate of Compliance (COC) – For facilities that have passed inspection after performing non-waived tests.
• Certificate of Accreditation (COA) – Awarded to facilities that perform non-waived tests based on their accreditation by CLIA-approved organizations.

How Much Does CLIA Certification Cost?

The cost of a CLIA Certification will depend on the type you are applying for. Applications must be submitted and fees paid every two years. The CLIA website has a fee schedule for each type of certification based on the number of specialties and annual test volumes. CLIA waived certificates and PPM certifications have a fee of $180 and $240, respectively, regardless of the number of specialties and annual testing volume.

What is CLIA Waived Certification?

CLIA waived certifications are for facilities that perform only waived tests. The Food and Drug Administration (FDA) is in charge of determining what tests fit into this classification. The FDA classifies waived tests as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” You can find a list of waived tests on the “Currently Waived Analytes” page of the FDA’s website. Common tests on this list include drug and COVID-19 rapid tests.

To attain a CLIA Certificate of Waiver or any other CLIA certificate, a facility must fill out and submit the CMS-116 Form located on the US Department of Health and Human Services website.