TAG:
laboratory managers
FDA Sends Warning Letter to Abbott Laboratories
CEO SUMMARY: On March 13, 2007, the Food and Drug Administration sent a warning letter to Abbott Laboratories’ Chairman and CEO, Miles D. White. The letter identified nine quality system violations and requested a satisfactory response by August 15, 2007. The warning letter is based on …
March 12, 2007 “Intelligence: Late Breaking Lab News”
It’s the first opportunity to see how a New York-area laboratory is doing at grabbing UnitedHealth business. Bio-Reference Laboratories, Inc. (BRLI) of Elmwood Park, New Jersey, announced earnings for its first quarter (ending on January 31) in its 2007 fiscal year…
Key Trends Drive Change for Clinical Laboratories
CEO SUMMARY: Technology plays an ever-growing role in reshaping the organization and operation of clinical laboratories. New technologies figure prominently in THE DARK REPORT’S 2007 list of key trends in the clinical laboratory industry. Technological advances in instr…
Middleware Produces Data In Real Time for Lab Managers
CEO SUMMARY: With sustained pressure on laboratories to cut costs, reduce errors, and raise quality, lab managers need faster access to detailed information about lab work processes. One solution is to use middleware to collect data in real time from the LIS and other sources, then analyz…
Feds Lift Ban on Doctor-Owned Specialty Hospitals
MANY OF YOU KNOW THAT on August 8 the Centers for Medicare and Medicaid Services (CMS) announced that it would resume issuing certificates for specialty hospitals that are owned by physicians. The timing of this decision certainly plays into the predictions of McKinsey & …
Three Ex-UroCor Execs Acquitted in Jury Trial
CEO SUMMARY: On June 30, 2006,three former executives of UroCor,Inc.,accused by the U.S. Attorney of anti-kickback and securities violations, stood and heard the jury verdict in their case. “Not guilty on all counts,” stated the jury foreman. Thus ended the effort to convict former ex…
Defense Attorneys Discuss Details Of UroCor Jury Trial
CEO SUMMARY: This was the first criminal case involving anti-kickback violations brought against executives of a public laboratory company. Federal prosecutors charged the defendants with offering inducements to referring physicians in several ways. Defense counsel rebutted the prosecutio…
New Lab Firm Life Cycle Demonstrated by Focus
CEO SUMMARY: When an investment group bought Focus Diagnostics, Inc. in 2000, its business objective was to increase the value of the business and sell it between year five and ten of its ownership. Thus, the announcement last Friday that Focus Diagnostics would be acquired by Quest Diagn…
Seoul, Korea Hosts Lab Automation Meeting
CEO SUMMARY: It was the fifth “International Conference on Laboratory Automation and Robotics.” Over the past decade, this meeting, started by the pioneers of clinical laboratory automation, has been the major forum to meet and discuss advances in all aspects of automation. This confe…
Consumer-Directed Health Plans To Be Healthcare’s Next Wave
“There is an opportunity for laboratories to put strategies in place to benefit from the changes triggered by wider use of CDHPs.” —Paul Mango CEO SUMMARY: It is widely known that growing numbers of employers are turning to consumer-directed…
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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