How to obtain the appropriate CLIA certificate

"CLIA" is the acronym for the Clinical Laboratory Improvement Amendments (CLIA) of 1988, Public Law 100-578. The CLIA program is administered by the Centers for Medicare and Medicaid Services (CMS). All facilities that test human specimens for the purpose of diagnosis, treatment or monitoring are subject to the CLIA regulations, regardless of who pays for the test. Each location where testing is performed must possess a CLIA certificate with a valid identification number.

Labs that perform only tests classified as "waived" by the FDA and agree to follow manufacturers instructions are required to have a valid Certificate of Waiver, and are referred to as a "waived laboratory". This includes POC urine drug screens.


Moderately Complex Laboratories may perform tests classified under CLIA as moderately complex as well as waived tests. Drug analyzers are classified as moderately complex devices and therefore require a Moderately Complex CLIA license. Moderately complex laboratories are subject to numerous personnel and quality assurance standards, must participate in a proficiency testing program, and agree to be inspected on a regular basis.


Highly Complex Laboratories may perform any type of test including DNA testing and other highly complex procedures. They are subject to more stringent personnel standards and quality assurance since many of the tests they perform have life and death consequences.


The information contained in this website has been compiled by CodeMap, L.L.C. who remains solely responsible for its content. The information provided is for general educational purposes only and may not be conclusive or exhaustive. Recent changes in applicable law, regulations and interpretations may not be reflected in the information contained herein. For technical questions, please contact Dr. Charles Root at (800) 522-3285.

CodeMap® has made every reasonable effort to ensure the accuracy of the information contained on this web site. However, the ultimate responsibility for correct coding and claims submission lies with the provider of services. CodeMap® makes no representation, warranty, or guarantee that this compilation of Medicare information is error-free or that the use of this information will result in Medicare coverage and subsequent payment of claims. Final coverage and payment of claims are subject to many factors exclusively controlled by CMS and its contractors.

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