However, an exception was created if a laboratory test could be performed with a minimal level of complexity and had a low risk of erroneous results. If these criteria were met, the manufactures of the test were allowed to apply for a CLIA-waiver. Approval of the CLIA-waiver application indicated that the test could be performed in a nontraditional laboratory setting if that site followed good laboratory practices and possessed a valid CLIA waiver.
This includes pharmacies. Surprisingly, this one piece of legislation passed nearly 30 years ago to regulate clinical laboratories created one of the most significant opportunities for pharmacists to play a valuable role in advancing public health.
Unfortunately, pharmacists have not yet taken full advantage of this legislation. Currently, there are more than 120 different CLIA-waived laboratory tests available in the U.S. Many of these tests can be performed without specialized equipment and provide results within 5-20 minutes.
Imagine the impact a pharmacist could have in the care of a patient if they were able to quickly identify patients with treatable infections like influenza or streptococcal pharyngitis versus those whose symptoms were caused by a non-treatable etiology that required only symptomatic management.