Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), 42 CFR 493, the federal law states any laboratory or facility that performs laboratory testing of human specimens for the purpose of providing information for the diagnosis, prevention or treatment of disease or impairment of, or the assessment of the health of, human beings is required to obtain a CLIA certificate and to meet certain requirements.

This rule applies whether or not the facility bills Medicare, Medicaid, other insurance, the patient, or provides the service for no charge. The type of CLIA certificate a laboratory must have depends on the type of testing the laboratory performs.

The University of Iowa Hygienic Laboratory oversees the CLIA Laboratory Program for the State of Iowa, under contract with Iowa Department of Inspections and Appeals and the Centers for Medicare and Medicaid Services. University Hygienic Laboratory provides the staff to administer the program and the laboratory surveyors to conduct clinical laboratory surveys.

The facilities, located within Iowa, must be in compliance with the Federal regulations. Iowa does not have additional state licensure or certification requirements.

If you wish to obtain an application form for a CLIA certificate, go to the Centers for Medicare and Medicaid Services (CMS) web site at www.cms.hhs.gov/clia. If you have questions concerning the CLIA program contact:

Nancy Grove, BS, MT (ASCP)
Senior Laboratory Consultant
University Hygienic Laboratory
102 Oakdale Campus, H101 OH
Iowa City, IA 52242
phone 800.421.IOWA or 319.335.4500
fax 319.335.4555
ngrove@uhl.uiowa.edu

Kristine Rotzoll, BS, MT (ASCP)
Laboratory Consultant
University Hygienic Laboratory
102 Oakdale Campus, H101 OH
Iowa City, IA 52242
phone 800.421.IOWA or 319.335.4500
fax 319.335.4555
krotzoll@uhl.uiowa.edu