CLIA Certificate of Waiver Basics You Should Know

CLIA stands for “Clinical Laboratory Improvement Amendment.” Every CLIA requires a certificate of certification allowing a facility, (mostly laboratories), to be allowed to use waived tests to examine a patient so that the health, diagnosis, and treatment determination can be made.

The Laboratory Field Services CLIA section that is filled out establishes that the lab has taken the proper steps for compliance with state and federal laws/regulations required by clinical laboratories for onsite inspections two time per year. CLIA certificates are just one of similar certificate types that are used as a way to both regulate and enforce laboratories. The process helps to ensure that, regardless of location, the laboratories have high standards of reliability and accuracy for test results produced.

The policies for CLIA as well as the responsibilities, including all of CLIA and CLIA Certificate of Waivers are shared by the government agencies of: CDC (the Center for Disease Control), the FDA (the Food and Drug Administration), and the CMS (the Center for Medicaid Services).

In other words, every facility that receives a CLIA Certificate of Waiver must pass all of the state and federal requirements that have been established. There are around 260,000 laboratores/facilities covered with CLIA Certificates of Waiver.

What is Required on a CLIA Certificate?

Every CLIA certificate includes a 10-digit number that is supplied by the U.S. Department of Health and Human Services. Each 10-digit number is unique and identifies that specific certificate.

Purpose of a CLIA Certificate of Waiver?

The CLIA Certificate of Waiver is a method to make sure that laboratory standards for accuracy reliability, and timeliness for patient laboratory results have been met. Healthcare providers use the diagnostic testing as a way to check and/or monitor a variety of patient conditions and disease states.

A CLIA Certificate of Waiver ensures that the entities are following the regulations set by the CLIA and gives permission for the laboratories for the assessment of a patient’s condition as long as the tests have been waived. The strict regulations established by the CLIA for laboratory testing include state and federal level CMS (Center for Medicare and Medicaid Service) must be met by a laboratory prior to being allowed to accept patient samples for the purpose of diagnostic testing.

Types of CLIA Certificates

The are many types of CLIA certificates, and each one is focused around the types of diagnostic testing that a laboratory or facility may run. Some of the tests, such as those on “human specimens for the purpose and/or treatment” is required by federal law and in some cases state law, to have a Certificate of Waiver. If there aren’t any on-site testing, no CLIA Certificate is required.

CLIA Testing Categories

The FDA has three categories for CLIA as IVD (in vitro diagnostic) based on how complex they are as: waived, moderate complexity, and high complexity. Those tests that have been waived under regulation 42 CFR 493.15c), or have been cleared for use in the home are automatically categorized as “waived” following their approval/clearance. Other tests listed in CLIA 42 CFR 493.17 that are approved/cleared, may receive the categorization of “moderate or high complexity”.

Who Can Apply for a CLIA Certificate of Waiver?

If a manufacturer has a test that has been confirmed under the category of “moderate complexity” they can request that the test is assigned as “waived” by submitting a CW (CLIA Waiver Application) to the FDA. Once they receive a CLIA Certificate of Waiver the laboratory is free to perform the test.

The CW requirements of a manufacturer include providing to the FDA the evidence that a test meets the statutory criteria for the waiver as set by the CLIA in 42 U.S.C. § 263a(d)(3). The specific statute indicates:

The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver]… are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that — (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.

Who Can Apply for a CLIA Certificate of Waiver?

Any facility or laboratory located in the United States that performs laboratory testing on human specimens for the purpose of health assessment or for the diagnosis, treatment, or prevention of disease are regulated under CLIA. The facility/laboratory must comply with all of the requirements of the CLIA and be able to provide documentation/proof as part of the submission process.

To attain a CLIA certificate, including a Certificate of Waiver, a laboratory or facility is required to complete and submit the SMS-116 Form located on the U.S. Department of Health and Human Services website. For information on how to apply see the CLIA’s How to Apply for a Certificate of Waiver. There is an additional CLIA Certificate of Waiver “Quick Startup Guide” that can be of assistance for the process.

For a list of the CLIA waived tests, see the FDA website.