HOW MANY OF YOU SAW THE NEWS STORY PUBLISHED LAST MONTH by The Wall Street Journal with the headline, “Is Lab Testing the ‘Wild West’ of Medicine?” It is the latest in a series of news stories about issues and questions involving the accuracy and quality of clinical laboratory tests delivered to patients daily here in the United States.
Journal reporter Thomas M. Burton’s subhead read, “Largely unregulated industry comes under FDA scrutiny; lab-developed test providers fight back.” He used that statement to frame the positions of the Food and Drug Administration, which is taking steps to regulate laboratory-developed tests (LDTs) versus those “laboratory-developed test providers” who are “fighting back.”
Without stepping in the middle of the arguments for and against FDA regulation, I would like to call your attention to the more serious issue that is represented by the Journal’s decision to research and write the story about the battle over federal regulation of LDTs. It reflects a recognition by the news media that consumers are interested in stories in which patients may be harmed because of problems in how a laboratory test was ordered, performed by the lab, and reported to the physician.
In recent years, the Milwaukee Journal-Sentinel has published well-researched stories about problems in state newborn screening programs, issues associated with how labs are licensed and accredited under CLIA, the lack of public transparency when CLIA assessors identify serious deficiencies that could cause patient harm, and related issues associated with the CLIA closure of the laboratory at Marymount Hospital in Cleveland last year.
Of course, the reported inaccuracies of lab tests performed on patients by Theranos in recent months have generated their own string of national news stories. All of these examples carry a message for pathologists and clinical laboratory executives: Consumers (and the media) in the United States are raising the bar on the quality of lab testing services.
All laboratory organizations should recognize this change in the popular culture. The clinical lab profession would be well-served to set its own quality bar higher and exceed the expectations of its customers, including patients, physicians, payers, and even lab regulators. The fight over FDA regulation of LDTs is just one round in this new battle.