Performance of the Kodak DT-60 physician's office analyzer as measured by CLIA-88 proposed evaluation criteria. Assessment of demographic and quality assurance factors influencing performance.

Abstract

The 1988 Clinical Laboratories Improvement Act (CLIA-88) proposes to mandate universal proficiency testing and internal quality assurance practices for all laboratories, including those in physician offices. For 3 years, we have provided an independent voluntary proficiency testing program to more than 400 physician office laboratories using Kodak DT-60 analyzers (Eastman Kodak, Rochester, NY). This unique data set enables us to evaluate, using the CLIA-88 proposed grading criteria, the ability of these laboratories to meet the proposed regulatory standards. Using the equivalent of a year's participation under the CLIA proficiency testing format (20 challenges per analyte), at least 88% would "pass," ie, achieve acceptable performance. We investigated the relationship between proficiency testing performance and several internal quality assurance practices as well as other factors commonly associated with quality performance, including analyst's professional background, monthly test volume, number of physicians served, and source of training on the instrument. The best indicator of successful performance in proficiency testing was on-site training provided by the manufacturer, as opposed to training provided by distributor personnel. We conclude that with proper on-site training and retraining, physician office laboratories will be able to meet the mandatory CLIA-88 proficiency testing requirements.