Though uncomplicated to perform, waived tests can still result in errors if staff members are not trained.
Waived tests – simple point-of-care laboratory tests that are exempt from most federal and state oversight – are widely viewed as having little or no potential to cause harms to patients. They are straightforward to perform, and can be administered by staff with little or no specialized laboratory background.
Now used to test for a wide variety of diseases and conditions – such as drug abuse, glucose levels, pregnancy and influenza – waived testing is steadily on the increase, now encompassing 120 waived analytes and more than 4,000 waived testing systems. More than 70 percent of the nearly 235,000 laboratory testing sites in the United States today have a Certificate of Waiver from the Clinical Laboratory Improvement Amendments (CLIA) if 1988.
But, despite the growing use of waived tests – and the popular view that they are virtually “error-proof” – problems are occurring at some waived sites. Federal government research is showing that failure to adhere to something as simple as following the directions in a waived test package insert can result in testing errors. This, in turn, has the potential to affect the quality of patient care. With more than 165,000 waived labs, the impact of waived testing errors on the patient population is cause for concern – even with CMS’s ongoing random surveillance of these sites…(Read More Here)