[Common diagnostic tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) in the United States].

The lower quality of laboratory testing in unlicensed physicians' office laboratories(POLs) had led to legislation of the Clinical Laboratory Improvement Amendments of 1988(CLIA '88) in the United States. This legislation extended laboratory regulations for quality control and assurance, personnel qualification, record-keeping, and proficiency testing to all laboratories regardless of size, complexity, or location, including POLs and ancillary testing sites in a hospital. According to the implementation of the CLIA '88 in 1992, all testing sites in this country must have inspections and a certificate issued by the federal government. The CLIA '88 has improved the quality of testing in POLs, forcing office physicians to deal with the problem of laboratory quality management, thereby increasing laboratory costs. Thus, compliance with the CLIA '88 standards is expensive. On-site testing in POLs has been reduced, discontinued, or changed as a result of the CLIA '88 legislation. A number of POLs have closed, and physicians have restricted test menus to those with simpler methodology(waived tests) because waiver laboratories do not require inspections by the government. Large portion of laboratory tests, which were formerly done in POLs, flow into the reference laboratory market as outreach tests. Currently, 77% of POLs are performing only waived tests or tests in the provider-performed microscopy procedures category, while only 23% have a certificate for moderate or high complexity methodology status. Thus, common diagnostic tests performed in POLs are predominantly based on the waived tests, which are largely different from those performed in Japan, with respect to test item and methodology.