Effects of CLIA '88 on the Physician Office Laboratory: A Survey of Midsized Pediatric Practices Before and After CLIA '88

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Abstract
A survey of midsized pediatric groups before and after the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) was done to determine what effects this legislation has had on pediatric office laboratory testing. The pediatric groups in the two time periods were similar in geography, numbers of doctors per group, and number of years in private practice. Despite increased administrative costs of running an office laboratory, there were no significant differences in the test menus offered (p >.05), the most commonly offered tests being streptococcal antigen test, urinalysis with microscopy, urine culture, mono spot test, automated complete blood count (CBC), and cholesterol. The numbers of these tests performed in the two time periods also did not differ significantly except for the automated CBC (mean 20/MD/month in 1990 versus 32/MD/month in 1995, p <.05). No laboratory failed inspection or incurred a fine. Although overhead has risen to comply with CLIA '88, the pediatric practices surveyed did not restrict their test menus, reduce their volume of testing, or fail inspection.