The influence of CLIA '88 on physician office laboratories

The study objectives were to examine the influence of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) on laboratory testing activities in physician offices, and to identify relationships between the characteristics of practices and their responses to the regulation.

The data come from a 1995 survey of physician office laboratories conducted by Mathematica Policy Research, and are supplemented by data from a 1991 laboratory survey. Primary care physician practices performing level I and level II tests in 1991 were resurveyed in 1995. Respondents were asked a series of questions pertaining to the types of laboratory tests performed in their offices, and whether CLIA '88 had any influence on the decision to change testing practices. We present descriptive statistics to examine differences across practices in response to CLIA '88. Significant determinants of the decision to drop or modify onsite testing activities are identified using multivariate analysis.

More than 64% of physicians surveyed cited CLIA '88 as a factor in their decision to reduce or eliminate in-office testing. The most striking effect of CLIA '88 appears to be on pediatric practices and practices in rural areas, of which more than 70% have reduced or eliminated onsite testing. Where the potential burden of compliance is smaller, as in large practices, CLIA '88 has had less impact.

CLIA '88 has had significant influence on access to laboratory testing services. According to the data from the 1995 survey, almost two thirds of physicians have eliminated some or all in-office tests. Of those physicians previously conducting in-office tests, 70% have chosen to send patients and specimens to outside facilities, resulting in greater inconvenience for patients and delays in diagnosis and treatment. These delays, and the potential for patient noncompliance stemming from the inconvenience of obtaining tests, have serious implications for the quality of medical care.