Waived testing—simple tests performed at the point of care that are “waived” from most federal and state oversight under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88)—is on the rise, and with it, the potential for quality problems.
Since 1993, the number of CLIA-waived tests has increased from just nine test analytes and 203 waived testing systems to 120 waived analytes and more than 4,000 waived testing systems. Waived tests are now used to detect everything from HIV, drug abuse, glucose levels, pregnancy, and Lyme disease, to infectious diseases such as influenza A and B and many others.
Waived tests have traditionally been considered to have little or no potential to cause patient harm. They are not complicated to perform, and they can be administered by individuals with little or no laboratory background or specialized training. These traditional expectations of waived tests, combined with their growing prevalence, pose a risk that testing sites may become complacent about following quality guidelines for waived tests.
But research shows that when workers fail to adhere to such basic instructions as following the directions in manufacturers’ inserts that accompany waived tests, testing errors can and do occur—and patient care may be impacted.
In a white paper entitled “Federal Government Questions Quality in Waived Testing,” COLA documented some of the errors detected at waived testing sites in the United States. According to the research, a persistent percentage of Certificate of Waiver sites do not meet minimal requirements to ensure quality testing. For example, more than 30 percent of the sites studied do not routinely follow manufacturers’ product inserts; perform Quality Control testing as specified by manufacturers’ instructions; or perform confirmatory testing, as required by the manufacturer and approved by the U.S. Food and Drug Administration (FDA). Moreover, the research showed that most waived laboratory directors and testing personnel did not have formal laboratory training or testing experience, and that there is a high level of turnover of waived testing personnel.
You may be asking “Are stringent quality measures really necessary when it comes to performing such simple tests?” Think of it this way: more than 70 percent of the nearly 235,000 laboratory testing sites in the United States have a Certificate of Waiver. That means that more than 165,000 labs have little to no federal regulatory oversight in the performance of their work, which ultimately impacts millions of patients across the United States.
The reality is that regardless of the complexity of the test being performed and the level of training possessed by the person doing the testing, maintaining and following the highest quality standards should always be a top priority.
There also is mounting evidence that counters the popular notion that errors in waived testing can cause no harm. For example, last May, one major global diagnostic device and services provider which focuses on rapid point-of-care diagnostics initiated a product recall for a waived testing product used to measure blood clotting time in patients on warfarin, following alleged errors that resulted in nine adverse patient outcomes, including three deaths.
Additionally, the FDA reported 100 deaths associated with potential glucose meter inaccuracies between 1992 and 2009 and 12,672 serious injuries from 2004 to 2008.
COLA believes 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. Studies show that increased educational outreach—combined with CMS’s random surveillance of Certificate of Waiver sites—has an impact on the performance of waived sites.
There are a wide variety of educational resources available for waived labs from CMS and other resources. COLA offers a comprehensive Waived Testing Manual, online courses, and other waived testing materials.
COLA also has begun documenting examples of adverse patient outcomes resulting from waived testing errors. We encourage our allied health partners and other stakeholders in government and industry to also be vigilant about such errors. The more data we can track, the easier it will be to advocate for the importance of education.
By encouraging the widespread use of educational tools by waived labs everywhere, laboratory and medical industry leaders, manufacturers, states, the Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), and other stakeholders will be able to proactively manage this important healthcare issue.
