Do Regulators Really Protect Patients, Consumers?

Do Regulators Really Protect Patients, Consumers?

IMAGINE, FOR A MOMENT, THAT ONE OF YOUR LOVED ONES had gone to Theranos during the past two years to get lab tests. Assume that your loved one was being tested for significant biomarkers that directly affected the care provided to your family member for significant health issues and that your loved one’s physician had ordered these lab tests.

Further, assume that the physician based clinical decisions on the lab test results Theranos reported. Now, imagine that you have just learned, two years later, that Theranos recently sent a letter voiding those lab test results to your family member and his/her physician. How would you feel about that news, particularly if your loved one had gotten the wrong clinical care because of an inaccurate or false lab test result that Theranos provided?

Am I describing a situation that has real consequences? Indeed, yes! Everyone in lab medicine, from phlebotomists and medical technologists to pathologists and clinical chemists, understands that every lab test result their clinical laboratories produce has a human life associated with it. That is why quality, accuracy, and reproducibility of clinical lab testing are the hallmarks of the lab medicine profession in the United States—and the envy of the world.

Next, how would you feel about the scheme of state and federal laboratory licensure and accreditation in the United States, if, in the case cited above, regulators knew about issues within Theranos, but, because of how CMS interprets the CLIA statute, it doesn’t make those findings public? Thus, a lab like Theranos can operate for months and years because of a combination of forbearance by regulators and the lack of public knowledge about deficiencies, whether minor or the type described in a CMS letter to Theranos as findings “of immediate jeopardy to patient health and safety.”

Set aside your role as a lab professional and take on the role of the patient or consumer. Is it good regulatory policy not to make lab deficiencies public—whether minor or major? How can a patient make an informed decision if these issues remain known to lab regulators, but not to the public?

These questions are all directly relevant to how Theranos got to this place and time. Either the regulatory system failed to detect these significant issues, or that information has been withheld from the public for many months or years. In this respect, the Theranos affair shows flaws in the existing scheme of lab regulation that Congress or CMS or both should address.

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