As Theranos Tries to Fix Up California Lab, Reports Surface It May Have Performed Inaccurate Blood Clotting Tests

As startup laboratory Theranos continues to struggle through its regulatory and compliance growing pains, it appears to be using the fingers of one corporate hand to keep better tabs on its operations, while those on the other hand are plugging holes in a precariously porous dam.

As Theranos announced it had hired a new lab director to oversee its troubled facility in Northern California to address issues cited by federal regulators, the Wall Street Journal reported earlier this month that the company had distributed test results from assays it knew may have been suspect.

The Centers for Medicare & Medicaid Services (CMS) had announced in January that the operations of Theranos' laboratory were deficient in several areas and were placing the safety of patients in immediate jeopardy in the area of hematology. Theranos was given 10 days to fix the problems or potentially lose certification of its laboratory and the ability to participate in the Medicare and Medicaid programs. In the wake of CMS' letter, The New York Times reported that Walgreens announced it would not be sending samples for testing to Theranos' California lab.

The decision was a significant setback for the Palo Alto, Calif.-based Theranos, which is attempting to market a wide arrange of lab tests that can be performed with just a few drops of blood at a price point 50 percent below that of Medicare rates.

"As part of that comprehensive review and our review of CMS's survey findings, we made personnel changes in our Newark, California lab, adopted enhanced policies and procedures, and provided additional support to the lab, as we became aware of any potential issues during the survey," Theranos said in a statement.

Meanwhile, the Wall Street Journal reported that Theranos conducted 81 prothrombin time/international normalized ratio assays (PT/INR) even though the company was likely aware that the results it was receiving when performing that test were erratic. The test is used to determine the clotting ability of a patient's blood, and is often used in conjunction with prescribing the dosage of blood thinners such as warfarin, which can be hazardous if the dosage is too large or small.

Theranos appeared to believe the issue would make headlines; two days before the Wall Street Journal published its article, it stated that it had "investigated all PT/INR issues raised by CMS, notified any potentially affected patients, and has no reason to believe that these issues have affected patients' health. The PT/INR issues identified by CMS related to tests run on conventional equipment using venipuncture samples."

Theranos also announced the hiring a new lab director for the Newark facility. The company reached high: The new hire is Kingshuk Das, M.D., a pathologist who was educated at Case Western Reserve University School of Medicine and completed his residency at Los Angeles County-USC Medical Center near central Los Angeles.

"We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients' health," Das said in a statement. "At its heart, the CMS report is about people and processes in one Theranos lab in the past, and does not reflect the current state of that lab."

Takeaway: Theranos is juggling the dual issues of fixing its laboratory operations while trying to convince the public that its testing platforms are safe.