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
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After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Clinical chemists at AACC pointed out that Holmes did not present data as promised. Instead, she did a speech that advertised her company’s latest medical lab analyzer

DATELINE: PHILADELPHIA—By now, the clinical laboratory industry and the world knows that Theranos Founder Elizabeth Holmes took the stage here last Monday at the annual meeting of the American Association of Clinical Chemistry (AACC). The content of her presentation was given wide play by the national press and, in general, Holmes appears to have failed to impress both the medical laboratory scientists in attendance and the journalists representing some of the world’s most prominent news outlets.

Among those in attendance was your Dark Daily editor, and I reported on the key elements of the presentation given by Holmes last week. However, the details contained within Holmes’ speech are only part of this important story. What is of equal or greater interest to medical laboratory professionals and pathologists is how their peers reacted to the invitation to have Holmes speak at the AACC meeting last week (a joint conference with the American Society for Clinical Laboratory Science—ASCLS), along with their reaction to what Holmes decided to present, their assessment of the diagnostic instrument she unveiled, and how they viewed the data she presented about certain assays performed by the Theranos “miniLab” device. (more…)

Hospitals Take Steps to Drive Down Medical Errors in Their Emergency Departments

Clinical laboratory managers are often part of the ER’s process improvement team

Hospital emergency rooms (ER) across the country are intensifying their focus on improving patient safety  and reducing errors. The cost of malpractice lawsuits filed after errors in emergency rooms is a major reason why growing numbers of hospitals are initiating formal programs to identify and eliminate the source of errors and wrong care provided to patients.

It probably won’t surprise most pathologists and clinical laboratory managers to learn that diagnostic errors are one significant source of malpractice claims that result from care provided by hospital emergency rooms, which can often be chaotic and overcrowded. Recently, The Wall Street Journal reported that a large percentage of medical errors in hospitals—and the resulting malpractice suits—occur because of mistakes in the emergency room. Studies of closed claims show that 37% to 55% of the malpractice suits are attributable to diagnostic errors. (more…)

IFCC WorldLab 2011 Conference in Berlin Provides Look at Developing Trends in Clinical Laboratory Testing Products

IVD manufacturers often introduce their newest technologies in Europe before the United States

DATELINE: BERLIN, GERMANY: With so many changes happening to clinical pathology laboratory testing in developed nations around the world, there is keen interest in evolving technologies, along with new medical laboratory instruments and automation products that clinical biochemists and pathologists will use, in the near future, to improve the quality of the clinical laboratory testing services they provide to physicians.

Here at the IFCC-WorldLab Berlin 2011 conference, pathologists and clinical chemists from the United States got an early peek at some of the latest and newest solutions developed by the world’s largest in vitro diagnostics (IVD) manufacturers. Many products on display at the IFCC WorldLab Exhibition have only been cleared for sale by the European Union. These products do not have clearance by the U.S. Food and Drug Administration (FDA) in the United States for sale and use in this country.