With more and more medical tests being performed outside the traditional clinical laboratory, AACC released a position statement emphasizing the need to ensure consistent high-quality testing at non-traditional facilities such as physician offices and pharmacies. The statement urges Congress to direct the Department of Health and Human Services (HHS) to study testing at non-traditional sites and to recommend steps to ensure patients get consistently reliable results to facilitate effective treatment.
The last few decades have seen a dramatic rise in the use of waived tests, which are tests that regulators consider easy to perform with a low risk of error. These methods are now used to diagnose, screen for, and monitor a wide range of conditions, from diabetes to pregnancy and strep throat to colon cancer.
Since 1993, the number of facilities outside of the traditional clinical lab that perform only waived testing has also grown more than 170 percent and these facilities now represent 71 percent of all clinical laboratory testing sites. Because waived tests are theoretically simple, these facilities operate with limited federal oversight and are subject to virtually no regulatory requirements outside of following manufacturers’ test instructions. However, past studies have found that about one-third of waived testing sites either don’t have or don’t follow test instructions, in addition to other significant, widespread deficiencies.
Raising the standard of testing at waived sites is critical to ensuring the safety of the many patients who rely on them. To accomplish this, AACC calls on Congress to direct HHS to perform a comprehensive assessment of all types of waived testing sites in order to develop a path to improvement for these facilities. To maintain these improvements, AACC recommends that the Centers for Medicare and Medicaid Services (CMS) annually inspect a minimum of 2 percent of waived testing sites to identify and correct problems. In addition, because individuals who perform waived tests oftentimes do not have formal training in laboratory medicine, AACC encourages waived testing sites to hire qualified clinical laboratory professionals as consultants to supervise and train personnel onsite.