Laboratory testing under the microscope: the Clinical Laboratory Improvement Amendments of 1988.

Currently, most clinical laboratories in the United States are not subject to significant federal oversight. Beginning in 1992, however, the Clinical Laboratory Improvement Amendments of 1988 n1 (CLIA-88) will subject hundreds of thousands of large and small clinical laboratories to a complex assortment of federal requirements. In particular, CLIA-88 will require laboratories engaged in medical testing to obtain a certificate for each category of tests that the laboratory performs. n2 To obtain the certificate, the laboratory will be required to meet detailed performance requirements in each applicable category of testing. Performing services outside the scope of the certificate will expose the laboratory and its owners and operators to denial of Medicare and Medicaid reimbursement, civil monetary penalties and in cases of intentional violations potential criminal sanctions. n3