ABSTRACT
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations. Since CLIA was implemented, waived testing has steadily increased in the United States. Surveys conducted during 1999-2004 by the Centers for Medicare & Medicaid Services and studies funded by CDC during 1999-2003 evaluated testing practices in sites holding a CLIA Certificate of Waiver (CW). Although study findings indicate CW sites generally take measures to perform testing correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. These issues are probably caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training. This report summarizes study findings and provides recommendations developed by the Clinical Laboratory Improvement Advisory Committee for conducting quality waived testing. These recommendations include considerations before introducing waived testing, such as management responsibility for testing, regulatory requirements, safety, physical and environmental requirements, benefits and costs, staffing, and documentation. They also cover good laboratory practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting, documentation, confirmatory testing, and biohazard waste disposal). They are intended to be used by those who would benefit from improving their knowledge of good laboratory practices. Continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient safety as waived testing continues to increase.
