Laboratories - Clinical Laboratory Improvement Amendments

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 under CLIA to be a laboratory and 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 is responsible for surveying laboratories for CMS. For more information on the certification process, contact the CLIA State Agency regional office (PDF) for your location.

Accreditation

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.

Application

HHSC, on behalf of the CMS CLIA program, uses Form 3225, Application for Certification – Supplement to CMS 116 to process CLIA certificate applications.

Fees

Do not send CLIA fee payments with the initial application. After an initial application has been received by the CLIA State Agency regional office and a CLIA number has been assigned, you will receive a fee coupon with which to submit your fee payment. For more information see the Centers for Medicare and Medicaid Services, CLIA Certificate Fee Schedule.

The mailing address for all CLIA payments is:
CLIA Laboratory Program
P.O. Box 530882
Atlanta, Georgia 30353-0882

Medicare Information

Section 6141 of the Omnibus Budget Reconciliation Act of 1989, Public Law 101-239, requires that laboratories participating in the Medicare program 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.

Resources

CLIA Waived Testing FAQ - Centers for Disease Control