TAG:
laboratory accreditation
Labs Should Prepare for Tighter CLIA Enforcement
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…
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 …
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 …
More Labs Actively Adopt Quality Management
CEO SUMMARY: With almost 300 speakers, attendees, and vendors in attendance from seven countries, Lab Quality Confab was a significant milestone for the global lab industry. On one level, it was a sign that the quality improvement trend has come of age. On another level, it provided ample…
There is Steady Convergence In Lab Operations Worldwide
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 lab…
Canadian Lab Confab Reveals Useful Insights
CEO SUMMARY: Last month, a group of Canadian early-adopter pathologists and laboratory directors came together for the first-ever Executive Edge forum to share best practices and other cutting-edge developments in laboratory management. Among the noteworthy developments is Canada Health I…
Change Beneath Surface Marks 2004 Lab Stories
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 reshap…
Congress Holds Hearing On Hospital Lab Fiasco
CEO SUMMARY: Problems at the laboratory of Maryland General Hospital came under scrutiny at a recent Congressional hearing. There was plenty of criticism and embarrassment for several entities which should have detected the problems and reacted to the situation more effectively. Serious q…
Baltimore Hospital Lab Problems Put Spotlight On CAP Inspections
CEO SUMMARY: Here’s an exclusive peek into a three-year battle between medical technologists wanting to do the right thing and a laboratory manager—backed by hospital administration—who aggressively stifled well-justified dissent. It is an inside look at one of the most grievous fai…
Growing Criticism Hits Maryland General Hospital Lab
CEO SUMMARY: “Like peeling back layers of rotten fruit, the deeper state and federal inspectors looked into the management of the hospital’s lab, the more problems they found.”–Editorial, Baltimore Sun, April 7, 2004. Public response to the inspection report of the Maryland Genera…
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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