Theranos—Theranos deployed inaccurate blood tests endangering patient safety, forced to void two years of results
Theranos equipment provided inaccurate results for an estimated one out of ten tests, causing thousands of negative patient experiences. Patients were misdiagnosed with conditions including diabetes, cancer, and heart attacks. A pregnant woman was falsely told she was miscarrying; another received incorrect results about a life-threatening ectopic pregnancy. In January 2016, CMS declared the Theranos Newark lab posed 'immediate jeopardy to patient health and safety' due to dangerously unreliable warfarin dosage testing. CMS revoked Theranos's CLIA certificate in July 2016 and the company was forced to invalidate two years of blood test results for tens of thousands of patients.
Scoring Impact
| Topic | Direction | Relevance | Contribution |
|---|---|---|---|
| Consumer Protection | -against | primary | -1.00 |
| Research Integrity | -against | primary | -1.00 |
| Overall incident score = | -0.590 | ||
Score = avg(topic contributions) × significance (critical ×2) × confidence (0.59)× agency (negligent ×0.5)
Evidence (1 signal)
CMS declared Theranos lab posed immediate jeopardy to patient health and safety
In January 2016, the Centers for Medicare and Medicaid Services sent a letter to Theranos based on inspection of its Newark, California lab, finding the facility caused 'immediate jeopardy to patient health and safety' due to unreliable warfarin dosage testing. CMS subsequently revoked Theranos's CLIA certificate in July 2016 and barred Holmes and Balwani from operating clinical laboratories for two years.