On Jan. 25, the Centers for Medicare & Medicaid released a letter it sent to the blood-test startup Theranos, informing the company an inspection of its Newark, California lab had found it to be deficient in five areas. CMS said deficiencies in one of those areas -- hematology -- put patients in "immediate jeopardy," which is defined by the agency as a situation likely to cause "serious injury or harm, or death" to patients.
Sounded serious, to say the least. But what CMS did not release are the actual problems it found in the lab that caused it to reach such a dire conclusion. Those were detailed on Form CMS-2567, called a Statement of Deficiencies. When we asked CMS for that, a spokesperson would only say the form would become "releasable" after Theranos' plan of correction was approved.
Those sources said CMS found that Theranos "ran an important blood test on 81 patients in a six-month period despite erratic results from quality-control checks meant to ensure the test’s accuracy," the Journal said.
The test, called the prothrombin time test, measures how long it takes blood to clot. Inaccurate results "can be especially serious for patients taking blood thinners such as warfarin" (better known as Coumadin), the paper said.