Who should monitor the point-of-care testing performed in an ambulance?
A. Any laboratory that performs testing on human specimens to obtain information that can be used for the diagnosis, prevention, or treatment of disease is subject to CLIA regulations. This includes mobile labs, ambulances, direct access testing, health screening fairs, and other temporary testing locations. All facilities that meet the definition of “laboratory” under CLIA must obtain an appropriate CLIA certificate before conducting patient testing. The Centers for Medicare and Medicaid Services ordinarily requires that each location have a separate CLIA certificate, but a parent location may hold the CLIA certificate for mobile testing units. According to the CLIA ’88 final rule, Federal Register (2003) [42 CFR 493.35 and 42 CFR 493.43], this exception applies to temporary testing locations that perform waived or provider-performed microscopy procedures, such as mobile units providing laboratory testing or health screening fairs. Not-for-profit or federal, state, or local government
