The Clinical Laboratory Improvement Amendments (CLIA) remains the most sweeping federal law affecting the laboratory industry. Its purpose is to safeguard the "accuracy, reliability, and timeliness" of patient test results. To accomplish that objective, CLIA broadened the regulatory reach of existing law to include all U. S. facilities, including physician operated laboratories (POLs), not previously subject to CMS oversight.
Twenty-three years later, CLIA is still in effect. The number of labs with direct oversight under its purview is shrinking due to the rise of so-called "waived testing" --simple, point-of-care-performed tests exempted from most federal and state regulations.
Since the enactment of CLIA, the number and types of waived tests have grown in both popularity and availability. They are routinely used in a range of sites, including pediatric, urology, family and internal medicine practices, as well as urgent care and other primary care clinics, to monitor conditions such as diabetes, hematology disorders and infectious diseases.
These tests can be performed by individuals with little or no laboratory background, in a bedside or chair side setting. Waived tests are often used to test for glucose, PT/INR, some chemical analytes, and infectious diseases such as influenza A and B.
They are simple to conduct, do not require staff with specialized training, and have a reputation for being relatively error-free. Further, they allow POLs to conduct more tests in-house without facing the regulatory burdens associated with moderate- and high-complexity tests. Learn more by clicking the link below.