How is it determined if a waived test is screening or definitive?

Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.

A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.

A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.

When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.