What is a CLIA Certificate of Waiver?

What is a CLIA Certificate of Waiver?

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require healthcare clinics and facilities to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.  A CLIA Certificate of Waiver is one type of certification that allows a healthcare clinic or facility to legally examine a person through certain types of tests called "waived tests."

What is a Waived Test?

Waived tests are test systems that have been determined by the FDA to
be so simple that there is little risk of error.  Examples include glucose testing, certain types of urine drug testing, pregnancy tests, and fecal occult blood tests.  The FDA lists all waived tests on its website at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

If what you are testing for does not appear on the FDA list, then it is not a waived test, and you need more than just a CLIA Certificate of Waiver to do it.  You would need a moderate or high complexity certificate (depending on the circumstances).

We know that all of this can be overwhelming.  That's why we will help you ensure that all tests you perform are waived tests.

Do I need a CLIA Certificate of Waiver if I do Point-of-Care tests?

Yes.  Point-of-Care tests are a type of laboratory test system. This means that prior to doing it, your clinic or facility must (i) have a CLIA Certificate of Waiver, and (ii) confirm that the specific Point-of-Care test has been approved by the FDA as a waived test.

I am not a clinical laboratory, so do I really need a CLIA Certificate of Waiver?

Yes.  Even though you are not what ordinary people would consider to be a clinical laboratory, the definition of laboratory under federal law includes clinics and other types of facilities such as substance use disorder treatment facilities and skilled nursing facilities.  

I work with a clinical laboratory, and it offered to handle my CLIA Certificate of Waiver for me.  Is that okay?

No! That is a kickback and violates the Eliminating Kickbacks in Recovery Act. 

Do I need a CLIA Certificate of Waiver if I do not bill for the tests?

Yes.  You are required to have a CLIA Certificate of Waiver regardless of whether you bill for the test.

Do I need to renew my CLIA Certificate of Waiver?

Yes, CMS requires you to renew every two years, and some states, like California, require annual renewals.  Also, you may need to periodically update your waiver prior to expiration.  For example, federal law requires updates for changes in ownership of the registered entity, changes in location and other contact information, and changes to your laboratory director.

How long does it take to get my CLIA Certificate of Waiver?

Once all of the paperwork has been submitted to the applicable regulatory agency, it will take about two months to receive your CLIA Certificate of Waiver. 

I perform Point-of-Care tests at multiple locations. Do I need a CLIA Certificate of Waiver for each location?

Yes. A CLIA Certificate of Waiver is required for each location.

How much does a CLIA Certificate of Waiver cost?

CMS charges $180, and some states, like California, may charge additional fees.  In addition to those charges, you may have consulting fees in excess of $1,000.00.

We structured our fees to be extremely affordable and fixed so that you know exactly what you pay and never a penny more.