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 certifying laboratories. For more information on the certification process, contact the appropriate zone office. See the City-Zone 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).

Fees

DO NOT send CLIA fee payments with the initial application. After an initial application has been received and a CLIA number has been assigned, you will receive a fee coupon with which to submit your fee payment. Click here to read the CLIA Certificate Fee Schedule.

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.

Audit Tool

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.

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Last Updated May 12, 2006