TAG:
management systems
Two U.S. Labs Pursuing ISO 15189 Accreditation
CEO SUMMARY: In their first public interviews, the nation’s only two laboratories to seek ISO 15189:2007 accreditation share insights about the process, along with its challenges and benefits. Both laboratories are in the final stages of implementation and expect to earn accreditation b…
First U.S. Labs Nearing ISO:15189 Accreditation
CEO SUMMARY: Laboratories, hospitals, and other health-care providers in the United States will increasingly be required to adopt quality management systems (QMS) as part of their regular operational routine. This is consistent with trends in other developed countries. Several U.S. labora…
Two Healthcare Trends Collide on These Pages
THIS ISSUE OF THE DARK REPORT YOU NOW HOLD IN YOUR HANDS demonstrates the perfect intersection of two trends. One trend, transparency in health outcomes and a public expectation of reduced medical errors, is a direct threat to laboratories which fail to deliver high-quality and accur…
ISO 15189 Work Advances at Meeting in Vancouver
CEO SUMMARY: Laboring quietly out of the public eye, an international work team of professionals, including representatives from the CDC, the FDA, and global in vitro diagnostics (IVD) manufacturers, has spent the past 14 years developing an important series of quality and safety standard…
ISO 15189 Accreditation Program Offered by CAP
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 …
Powerful Trends Reshaping Anatomic Path Profession
CEO SUMMARY: THE DARK REPORT presents its newest biannual review of macro trends reshaping the anatomic pathology profession. These macro trends reveal a profession undergoing change and transformation on multiple fronts. New competitors are crowding into the market, payers and accreditin…
New Study Demonstrates How Lean Labs Outperform Peers
CEO SUMMARY: A new study provides powerful evidence that laboratories using Lean, Six Sigma, and similar process improvement methods consistently outperform conventionally managed laboratories. Using data sets from 100 laboratories, including 14 Lean/Six Sigma laboratories, consultant Tho…
Busy Year Demonstrated By Top Ten Lab Stories
CEO SUMMARY: As it turns out, 2007 has been an action-packed year with lots of events, plenty of changes, and the promise of even faster evolution across all sectors of the lab testing marketplace. THE D…
ISO 15189 Gains Favor For Lab Accreditation
CEO SUMMARY: Volunteers for the Clinical and Laboratory Standards Institute (CLSI) are in the midst of an 18-month project to help five …
Shiel Medical Lab Grows In Tough NYC Market
CEO SUMMARY: There’s a new lab player emerging in the New York metropolitan market. Shiel Medical Laboratory of Brooklyn, New York, is growing steadily and now reports $50 million in annual revenue. It is taking full advantage of the managed care contracting turmoil and adding new clien…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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