Laboratories must comply with the Clinical Laboratory Improvement Amendments (CLIA) 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 Group staff is responsible for surveying laboratories for CMS. For more information on the certification process, contact the appropriate zone office. See the Zone Address List to find your appropriate zone office.
CLIA Waived Testing FAQ- CDC Link
Laboratories may be accredited. Accrediting programs are: Joint Commission for the Accreditation of Healthcare Organizations (JCAHO); American Osteopathic Association (AOA); American Association of Blood Banks (AABB); College of American Pathologists (CAP); Commission on Office Laboratory Accreditation (COLA) and American Society of Histocompatibility and Immunogenetics (ASHI).
The CMS CLIA 116 application should be mailed to the Health Facility Compliance zone office geographically closest to the facility. See the Zone Address List to find your appropriate zone office.
The Office of Management and Budget (OMB) approved the CMS-116 form for a period of three years (through 8/31/2017). This means that the new form CMS-116 can now be used by the laboratory community. Accordingly, the form and its accompanying instructions are now available on the CMS Website by using this link: http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf.
DO NOT send CLIA fee payments with the initial application. After an initial application has been received by the Health Facility Compliance zone 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
PO Box 530882
Atlanta, GA 30353-0882
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.
Audit tools are provided for use by your facility in preparation for a federal certification survey. We suggest you conduct an audit of your facility’s compliance to federal standards prior to the scheduled or unannounced survey.
- CLIA Survey Federal Audit Tool (Report, CMS-1557). PDF File (434KB, 4 pgs.)
- CLIA Survey Federal Worksheet. Word File (695KB, 46 pgs.)