Morbidity and Mortality Weekly Report, Volume 54, Number RR-13, November 11, 2005. Good Laboratory Practices for Waived Testing Sites: Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory Improvement Amendme

摘要

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).