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.
[Rinsho Byori 50 : 61〜67, 2002]
*Department of Laboratory Medicine, National Defense Medical College, Tokorozawa 359-8513
受付2001年7月18日・受理2001年10月12日
*防衛医科大学校検査部(〒359-8513 所沢市並木3-2)
E-mail :yutakemu@interlink.or.jp