Practice Patterns of Testing Waived Under the Clinical Laboratory Improvement Amendments

Abstract

Just more than half of waived laboratories in 3 diverse states follow manufacturer's instructions for recommended QC and QA. These instructions help ensure that the test will produce results that have an insignificant chance of an error. Although we did not study the impact of this and other findings on patient care, the results show that imposing good laboratory practices by regulation alone was insufficient to ensure quality laboratory results in any location evaluated. A system that can continually provide accessible education on laboratory practices, coupled with new thoughts on the regulatory environment, is in order.