News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

For Embattled Medical Laboratory Company Theranos, Bad News Keeps on Coming After Two Federal Inspections Show Problems in Certain Lab Practices

High rates of variability from one drop to another raise questions about the reliability of point of care testing equipment and companies that collect lab specimens only with finger sticks

Since last fall, one news report after another has come out with bad news for Theranos Inc., the high-profile medical laboratory company. The reports have ranged from dissatisfaction among Theranos’ partners, such as Walgreens and Capital BlueCross, to failed inspection reports from the federal Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA).

In response, the embattled lab company in Palo Alto, Calif., has maintained that it is doing everything it can to correct any deficiencies in its clinical laboratory testing methods and to ensure its partners that its processes are scientifically sound and its methods valid. (more…)

Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”

Experts say that CLIA inspections are becoming more rigorous, with inspectors taking more interest in how medical labs comply in the areas of personnel, PT, and quality control

Recent reports indicate that regulatory inspections of clinical laboratories are getting tougher. Some pathologists and medical lab managers acknowledge that they’ve had to scramble in response to the unexpected deficiencies identified by Clinical Laboratory Improvement Amendments (CLIA) inspectors following inspections of their labs.

These developments make it more important than ever that clinical laboratories work to become “inspection ready.” At the same time, it is essential that every laboratory compliance officer stay up to date with changes in how CLIA and other regulatory inspections are conducted.

Unwelcome Publicity When Medical Lab Regulators Find Deficiencies

There’s another factor at play in this unfolding story. News headlines immediately follow when federal and state lab regulators discover a problem with a laboratory and the quality of the test results that it is reporting. This raises the stakes for every lab director, because even highly respected medical laboratory organizations can find themselves at the center of unwelcome attention when the public becomes aware of inspection deficiencies. (more…)

;