The Physicians' Office Laboratory

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Abstract
Objectives To contrast practices of physicians' office laboratories in the years 1988 and 1996 and ascertain physicians' perception of the effect of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Design Mailed surveys to members of the Illinois chapter of the American Academy of Pediatrics in 1988 and 1996. Subjects There were 525 and 980 respondents in 1988 and 1996, respectively; analyses included 282 and 374 surveys representing offices where direct patient care was provided in a nonhospital setting. A paired analysis was also conducted on 101 offices that responded to both surveys. Results There was a decline from 1988 to 1996 in the percentage of offices doing in-office laboratory testing (93% to 84%, respectively; χ2test;P<.01) and median number of types of tests (6 tests vs 4 tests; Mann-WhitneyUtest;P<.001). Decreases (χ2test;P<.01) were seen in the proportion of offices offering throat culture for group A streptococci (63% to 33%), urinalysis (54% to 33%), urine culture (53% to 22%), rapid hemagglutination slide test for mononucleosis (42% to 17%), theophylline level (27% to 4%), and total cholesterol (22% to 13%). The proportion of offices offering urine dipstick, hematocrit or hemoglobin, complete blood cell count, and stool occult blood tests remained stable. For solo practitioner offices only, streptococcal antigen detection testing decreased (66% to 39%; χ2test;P<.001). Findings in the paired analyses were similar. In 1996, more offices participated in a formal proficiency testing program (60% vs 11%; χ2test;P<.001). The CLIA guidelines were deemed responsible for increased documentation (58%), discontinuing 1 or more tests (56%), increased frequency of quality control (50%), joining a proficiency program (40%), and increased cost to patients (32%). Conclusions These surveys provide large-scale data concerning change in office-based laboratories of physicians serving children during an 8-year period. Office laboratories reduced their menu of tests and enhanced documentation and quality control for the tests that were done. Data like these in multiple specialties over time contribute to a comprehensive picture of the effects of CLIA on office laboratory practices.

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