Good Laboratory Practices for Waived Testing Sites, provided by the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC), includes a summary of waived testing based on study findings by the Centers for Medicare & Medicaid Services, CDC, and the HHS Office of Inspector General.

The study focused specifically on laboratories performing waived testing. Waived tests, as classified under the Clinical Improvement Amendments of 1998 (CLIA), are simple, low-risk tests that can be performed with no routine regulatory oversight. Since CLIA was implemented in 1992, the number of waived tests and number of sites that perform waived tests has dramatically increased.

The purpose of the Good Laboratory Practices for Waived Testing Sites report is to highlight quality issues identified in waived testing sites on the basis of the surveys conducted by CMS and CDC. In addition, the report presents recommendations developed by the Clinical Laboratory Improvement Advisory Committee (CLIAC) for improving the quality of waived testing. The report indicates that “By following these recommendations, errors that could potentially lead to patient harm and the associated morbidity and mortality can be prevented.”

Although the report indicates that testing sites generally take measures to perform testing correctly, it raises quality concerns about practices that could lead to errors in testing and poor patient outcomes. According to the report, these quality issues are caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training.

The report summarizes study findings and provides recommendations developed by CLIAC for conducting quality waived testing including considerations for introducing waived testing and good laboratory practices for all phases of testing.