Texas State Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Directors
- Online Access to CLIA Certificates QCOR (See below)
- Pay CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Texas Health and Human Services, Public Health Division. Clinical Laboratories.
On behalf of the CMS CLIA program, HHSC uses Form 3225, Application for Certification – Supplement to CMS 116 to process CLIA certificate applications.
(1) 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).
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.
Online Access to CLIA Certificates
CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool. All certificates generated after September 27, 2023 should be available for download. Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top). When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.