By Joseph Burns, from the Volume XXI No. 15 - November 3, 2014 issue
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased
By Robert Michel, from the Volume XVIII No. 15 - November 7, 2011 issue
CEO SUMMARY: It was record attendance at the major pathology congress which took place in Hangzhou, China, last month. Because of the ongoing growth of China’s economy, the demand for healthcare—and for high-quality clinical lab and pathology testing—is rising at an accelerated pace. During his visit to the pathology congress and Chinese hospital labs, your
By Robert Michel, from the Volume XVII No 14 - October 4, 2010 issue
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by the lab industry press is the simple fact that, if the FDA were to
By Robert Michel, from the Volume XVI No. 17 - December 14, 2009 issue
In Nigeria, there is an aggressive effort underway to raise the quality of medical laboratory testing. One major element involves inspection of clinical laboratories throughout the nation by teams of laboratory professionals working with the Medical Laboratory Science Council of Nigeria (MLSCN). During 2009, MLSCN has closed 938 substandard and unregistered medical laboratories in all
By Robert Michel, from the Volume XVI No. 9 - June 29, 2009 issue
In recent weeks, the laboratory at Blanchard Valley Hospital in Findlay, Ohio, received its accreditation for ISO 15189: Medical Laboratories. With this achievement, Blanchard Valley becomes only the third lab in the United States to become ISO 15189-accredited. Blanchard Valley’s laboratory used the ISO 15189 accreditation services provided by the College of American Pathologists (CAP).
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By Robert Michel, from the Volume XV No. 3 - March 3, 2008 issue
CEO SUMMARY: Two strong trends in laboratory management can be seen in the College of American Pathologists’ (CAP) move to offer accreditation to ISO 15189:2007. The first trend is the movement toward quality management systems such as Lean and Six Sigma. The second trend is the global convergence of laboratory operations. Also, a growing number
By Robert Michel, from the Volume XIII No. 17 - December 18, 2006 issue
IS THERE AN ACCELERATING CONVERGENCE OF LABORATORY OPERATIONS by major clinical laboratories throughout the world? In recent weeks, THE DARK REPORT has seen tantalizing evidence that the answer to this question should be “yes.”
This trend has strategic implications for independent commercial laboratories and hospital-based laboratories in the United States. It also has implications for in
By Robert Michel, from the Volume XI No. 17 - December 13, 2004 issue
CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2004.” These are the events we consider most important to the lab industry during the year. However, in contrast to past years, 2004 lacked the types of blockbuster events which radically change and reshape the competitive landscape. Instead, 2004 was a relatively
