Diagnostic Errors Get the Attention of the Institute of Medicine, Reinforcing Efforts by Nation’s Clinical Pathology Laboratory Scientists to Improve Patient Safety

Along with its assessment of the rate of errors in diagnosis, the IOM has a plan to improve, but will doctors accept the IOM’s advice, or continue business as usual? Diagnostic errors in the American healthcare system is a problem that is now on the radar screen of policymakers at the Institute of Medicine (IOM). Pathologists and clinical laboratory professionals will welcome this development, because recommendations from the IOM carry weight with Congress. Thus, should the IOM develop...

Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device

FDA details findings from visits by five federal inspectors at California clinical lab company over 10 days in late August and early September; heavily redacted reports outline 14 compliance deficiencies Two reports released Tuesday by the Food and Drug Administration (FDA) brought more bad news to Theranos, of Palo Alto, California. The clinical laboratory company has been the subject of much unwanted press coverage since October 15. In the FDA inspection reports, Theranos is required to...
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