Laboratories - Clinical Laboratory Improvement Amendments

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.


Accreditation

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).


Application

Please see the CLIA Application Form, which includes all necessary forms listed below.

The Texas Department of State Health Services on behalf of the Centers for Medicare and Medicaid Services (CMS) CLIA Program requests the following information to apply for a CLIA Certificate:

  1. 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 - (enclosed with CLIA application form).

  2. Listing of Tests Performed in the Facility with a direct phone number to the named laboratory director’s office in order that we may contact them and confirm that they are affiliated with the laboratory - (enclosed with CLIA application form)

  3. Qualification Appraisal (enclosed with CLIA application form) along with copies of educational documentation, training and experience for the laboratory director and technical consultant or technical supervisor, which meets the CLIA qualifications for the position for the type of CLIA certificate for which you are applying. See CLIA personnel qualifications (PDF) for more information.

  4. Disclosure of Ownership – (enclosed with CLIA application form) Please see 42 CFR §493 for a complete listing of the CLIA Laboratory Requirements.

If you have any questions about the application process, please call your CLIA zone office. Please forward completed documents to your appropriate CLIA Zone Office in order for your CLIA application to be accepted and processed. Your application will not be processed until all requested information is received and approved by this office.


Fees

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


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


External links to other sites are intended to be informational and do not have the endorsement of the Texas Department of State Health Services. These sites may not be accessible to people with disabilities.

Last updated October 10, 2016