CLIA Applicability

6002 - CLIA Applicability (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The complexity or volume of testing conducted does not exclude an entity from being subject to CLIA, but these factors determine which requirements a laboratory must meet for CLIA certification, and the fees to be paid by the laboratory. These requirements apply whether or not the laboratory or entity bills the patient for the services or is paid for the services by Medicare or Medicaid. Certain types of laboratories and laboratory tests are NOT subject to meeting CLIA requirements. These include: • Any facility or component of a facility that performs testing strictly for forensic purposes; • Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients; • Components or functions of laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed that meets SAMHSA guidelines and regulations. (However, all other testing conducted by a SAMHSA certified laboratory is subject to this rule.); • Laboratories under the jurisdiction of the Department of Veterans Affairs; • Department of Defense (DoD) laboratories are subject to requirements that CMS has determined to be comparable to those in CLIA. The DoD is responsible for assuring compliance with these requirements and for oversight of its laboratories under a Memorandum of Understanding (MOU) between the Secretary of HHS and the Secretary of DoD. • Laboratory testing conducted in conjunction with the provision of home health or hospice care in an individual’s home, where the home health agency or hospice employee merely assists the individual in performing a test, since tests performed by individuals in the home are not subject to CLIA; (See section 6010.1.2.1) • Laboratories located in and licensed or approved by a State with a CMS- approved State laboratory licensure program (i.e., CLIA-exempt as approved under 42 CFR part 493, Subpart E); • Facilities which serve only as collection stations. A collection station receives specimens to be forwarded to a laboratory performing diagnostic tests; • Radiological facilities that perform only imaging procedures (e.g., x-rays, ultrasounds, Magnetic Resonance Imaging, Computerized Tomography); • Facilities performing only physiological testing, e.g. spirometry, slit-lamp test for eyes, breath analysis, pulse oximetry; and • Any facility or component of a facility that performs substance use disorder testing (such as for alcohol and/or drugs) solely for employment purposes (such as disciplinary, administrative, or legal action). NOTE: Any entity (including any facility or component of a facility) performing substance use disorder testing (including drug or alcohol testing and/or screening) where the test results may be used for the purpose of offering, referring or making available treatment to the individual, must obtain an appropriate CLIA certificate and meet the applicable CLIA standards or cease testing. If a laboratory is performing testing subject to CLIA and does not obtain the appropriate certificate, it is in violation of §353 of the PHSA and subject to specified penalties. Such cases or suspected cases should be forwarded to CMS for referral to the Office of the Inspector General (OIG). (See section 6036)