Report: Theranos continued blood tests even as quality checks revealed flaws
- Theranos continued to run a blood test on 81 patients even after quality-control reviews revealed differing results, the Wall Street Journal reports. The Centers for Medicare and Medicaid Services had previously sent a letter to the blood-testing firm citing deficiencies including some which "pose immediate jeopardy to patient health."
- In the January letter, CMS specifically flagged hematology as an area of concern, among four other categories. Theranos allegedly ran a blood test used to determine how long it takes blood to clot despite indications of deviant results, according to the Wall Street Journal report.
- After sending Theranos the letter, CMS granted the company a one-week extension to respond and correct the issues raised. The new submission deadline passed on February 12th.
In its letter, CMS had asked Theranos to demonstrate corrective action for patients affected by the deficiencies, as well as details on changes made to ensure the issues would not occurr again. If the deficiencies aren't resolved, Theranos could potentially lose its certification.
No details have emerged of CMS' review of the company's compliance submission.
After the damaging CMS inspection first came to light, Walgreens decided to termporarily shut down one of Theranos' Wellness Centers in Palo Alto, CA, in addition to stopping sending blood samples to Theranos' lab in Newark, CA.
The company has recently had a fall from grace as reporting from the Wall Street Journal discovered Theranos uses its propriertary finger-prick blood testing technlogy in far fewer tests than it markets itself as doing.
According to the Wall Street Journal, results from the quality-control checks on the hematology test were more than two standard deviations from the lab's typical result. Testing for blood clotting can be an important part of treatment for patients at risk of stroke or are taking blood thinners.
- Wall Street Journal Theranos Ran Tests Despite Quality Problems
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