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.
Waived Site Research Findings
COLA documented some of the government’s recent findings about waived testing errors in a white paper, entitled “Federal Government Questions Quality in Waived Testing.” According to the research, more than 30 percent of the sites studied are not following quality practices, such as always following manufacturers’ product inserts, performing the Quality Control testing that test manufacturers specify or doing the confirmatory testing required by manufacturer and approved by the FDA.
Of equal concern is that the waived sites studied also were found to have a high level of turnover of waived testing personnel, and that most of their laboratory directors and testing personnel did not have formal laboratory training or testing experience.
There is also documented evidence that patient harm can and does occur as a result of improper waived testing. For example, the FDA reported 100 deaths associated with potential glucose meter inaccuracies between 1999 and 2009 and 12,672 serious injuries from 2004 to 2008.
More Education Needed
At COLA, we believe that regardless of what type of lab test is being performed – high or moderate complexity or waived – adhering to the highest quality standards should always be a top priority.
We believe that more education is needed for Certificate of Waiver site directors and testing personnel, stressing the importance of following manufacturers’ instructions, adhering to expiration dates, performing Quality Control testing and proper documentation and recordkeeping.