Laboratories must comply with the Clinical Laboratory Improvement Amendments of 1988. CLIA requires all entities that perform even one test, including waived tests on "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain federal requirements. If an entity performs tests for these purposes, it is considered to be a laboratory under CLIA and the entity must register with the CLIA program.
Laboratories are not state licensed. The Secretary of the DHHS directs state health agencies or other appropriate agencies to determine if health care entities meet federal standards. This helping function is termed "CLIA certification".
Health Facility Compliance Unit staff are responsible for inspecting laboratories for CMS. For more information on the certification process, contact your regional office (PDF).
Laboratories may be accredited. Accrediting programs are: Joint Commission for the Accreditation of Healthcare Organizations; American Osteopathic Association; American Association of Blood Banks; College of American Pathologists; Commission on Office Laboratory Accreditation and American Society of Histocompatibility and Immunogenetics.
On behalf of the CMS CLIA program, HHSC uses Form 3225, Application for Certification – Supplement to CMS 116 to process CLIA certificate applications.
Do not send payment for CLIA fees to HHSC. Follow the instructions on the user fee coupon generated by CMS to make a payment.
When submitting a check, always include the CLIA ID number.
Fees for certificates are billed biennially. The amount is based on certificate type (for Certificates of Waiver and PPM) and the annual volume of testing and number of laboratory specialties performed (for Certificates of Compliance and Accreditation).
For more information, visit the CMS CLIA Certificate Fee Schedule.
To make a payment online, CMS utilizes Pay.gov.
Section 6141 of the Omnibus Budget Reconciliation Act of 1989, Public Law 101-239, requires laboratories participating in the Medicare program to comply with CLIA requirements. Therefore, virtually all laboratories in Texas must obtain a CLIA certificate to operate and be eligible for payment under Medicare and Medicaid.