Rapid human immunodeficiency virus testing is often conducted in nonclinical settings by staff with limited training, so quality assurance (QA) monitoring is critical to ensure accuracy of test results. Rapid tests (n ؍ 86,749) were generally conducted according to manufacturers' instructions, but ongoing testing competency assessments and on-site QA monitoring were not uniformly conducted.In 2003, rapid human immunodeficiency virus (HIV) tests became available that were waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and HIV testing began to be conducted in nonclinical settings by nonlaboratory staff (3). Because testing outside of clinical settings may affect result accuracy, monitoring to ensure that rapid testing is conducted in a manner that is consistent with manufacturers' instructions is essential. The Food and Drug Administration requires testing facilities that plan to perform waived rapid HIV testing to develop quality assurance (QA) plans which include site-specific testing procedures, plans for training testing personnel, and development of systems to identify and correct mistakes (3, 4). Mistakes that can occur during the testing process include performing testing outside of recommended temperatures, collecting specimens incorrectly, documentation errors, improper performance of testing, and incorrect interpretation of results (7). Adherence to QA procedures and ongoing test performance monitoring should reduce the number of testing mistakes that occur and increase the accuracy of results (5,6,8,13).The Centers for Disease Control and Prevention (CDC) developed guidelines for the implementation and operation of rapid test QA programs (4). The CDC recommends that testing sites participate in external quality assessments to evaluate how well testing is being performed. Examples include (i) proficiency testing (PT) programs which provide panels of samples with known results; (ii) competency assessments which evaluate the ability of individuals to read test devices, such as interpreting pictures of rapid test devices; and (iii) QA monitoring in which someone outside the organization observes testing (4).To characterize QA practices and outcomes, the CDC conducted postmarketing surveillance in conjunction with 17 state and city health departments