Quality clinical laboratory testing is the key to improving healthcare outcomes, says a recent statement from the American Society for Clinical Pathology (ASCP). The statement was issued in response to the decision by Theranos, Palo Alto, Calif, to throw out 2 years’ worth of results from diagnostic testing performed using the firm’s highly touted Edison blood-testing devices.
In the middle of May, Theranos notified the Centers for Medicare and Medicaid Services that it had voided all of the 2014 and 2015 test results from its Edison blood-testing devices, a technology that was said to be capable of running multiple tests on a few drops of blood. Theranos marketed the test directly to consumers at a fraction of the cost of tests conducted in traditional clinical laboratories.
“This clearly demonstrates the value of quality laboratory testing,” says E. Blair Holladay, PhD, SCT(ASCP)CM, CEO of ASCP. “For patients, accurate test results matter in order to get the right diagnosis and the right treatment. If it were my life on the line, I’d want a test that was performed in a clinical laboratory by a pathologist or certified medical laboratory professional.”
Inaccuracies in testing can lead to misdiagnosis and ineffective treatment, says Jack Hager, MS, MT(ASCP)SBB, former CEO of the American Red Cross National Testing Laboratory, Portland, Ore, and a past chair of the ASCP council on laboratory professionals. The greater the inaccuracy, the more likely a misdiagnosis or ineffective treatment, he adds.
“Any process adjustment that a manufacturer implements that does not maintain the quality associated with the license of the original product puts the accuracy of the testing and by extension, patients at risk,” says Hager. “Changes that affect quality are counterproductive in providing therapeutic and diagnostic testing services to patients.”
Laboratory tests drive most medical decisions, underscoring the important role that clinical laboratory professionals play in the delivery of healthcare, according to ASCP.
For reasons of patient safety and quality laboratory testing, ASCP supports personnel standards for laboratory professionals. These standards could take the form of practice requirements, certification requirements, or licensure.
“There is great value in following the process of test development with transparency to all stakeholders: scientists, clinicians, consumers, and investors,” says Hager. “The scientific and medical profession’s scrutiny of diagnostic testing is a long and thorough process, as it should be if we are to ensure patient outcomes.”
For more information, visit ASCP.