Waived tests and testing

Eighty-one percent of U.S. laboratories operate under a certificate of waiver or a provider-performed microscopy certificate, which allow them to perform a strictly defined subset of tests essentially without oversight. Waived tests, under the Clinical Laboratory Improvement Amendments statute, are required to be “simple” and to have an “insignificant risk of an erroneous result.” The number of analytes and individual test systems available as waived methods is large and increasing. Infectious disease tests available in waived format include Helicobacter pylori antibody, HIV-1 and 2 antibody, Influenza A/B antigen, Lyme antibody screen, Monospot, respiratory syncytial virus (RSV) antigen, RSV antibody, and Streptococcus group A antigen. Waived tests represent a compromise between access and quality of care. Quality problems in waived testing settings, demonstrated by state and Centers for Medicare and Medical Services (CMS) surveys, suggest that laboratory professionals could improve care by supporting waived testing laboratories, if systems to facilitate such interactions can be developed.