by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP)
The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) created the concept of waived tests which are defined as tests that are so simple to perform, and produce accurate results so reliably, as to render the likelihood of erroneous results negligible; and which also pose no reasonable risk of harm to the patient even if the test is performed incorrectly. Thus, these tests are exempt from federal requirements for personnel qualification, training, and competency assessment; quality control (except as specified by the manufacturer), proficiency testing, quality assessment, and the need for routine inspection.
If you’re like many physicians and Point of Care (POC) laboratories, you may be dealing with suboptimal performance from some of your current diagnostic methods. For example, conventional Rapid Influenza Diagnostics Tests (RIDTs) vary in terms of sensitivity and specificity when compared with viral culture or reverse transcription-polymerase chain reaction (RT-PCR). Product insert information and research publications indicate that in general, RIDTs sensitivities are approximately 50-70%.