TAG:
quality system
First ISO-Designed Clinical Lab Improves Outcomes, Costs
CEO SUMMARY: In the first 14 months of operation, Kaiser Permanente Northwest’s new automated regional laboratory facility, the nation’s first designed by an ISO-9000-certified lab organization, is yielding big gains in both productivity and outcomes. In its high-volume core lab, prod…
Kaiser Permanente NW Incorporates ISO-9000 In Regional Lab Design
CEO SUMMARY: After achieving its ISO-9000 certification, Kaiser Permanente Northwest’s laboratory division accomplished another distinction. It became the first lab in the nation to use the principles of ISO-9000 to design, build and operate a new, state-of-the-art, automated laboratory…
Patient Safety is Related to “Quality Management”
REMEMBER BACK IN 1997 WHEN LABORATORY COMPLIANCE PROGRAMS were mandated by Medicare officials? That was a big thing in the laboratory industry. Every laboratory organization in the United States scrambled to assess their laboratory’s operating practices, develop policies, and create a compliance ma…
Major Changes at Dade Behring Soon to Be Visible In Lab Market
Its recent financial restructuring now complete, Dade Behring prepares a “brand building” campaign CEO SUMMARY: Dade Behring is poised to become a tough and high-profile competitor in the laboratory diagnostics marketplace. Earlier this month,…
Dynacare, LabCorp, IMPATH, Visible Genetics, Abbott Labs
ACTIVITY AT DYNACARE HINTS AT POSSIBLE SALE, LABCORP MAY BE BUYER With Quest Diagnostics Incorporated snapping up independent lab companies right and left in recent months, the question asked by many is “Where’s Laboratory Corporation of America?” On …
ISO 9000 Growing Across Lab Divisions of Quest Diagnostics
CEO SUMMARY: Currently the American healthcare system is struggling to evolve away from its “cottage industry” roots and adopt modern corporate management methods. Within the clinical laboratory industry, Quest Diagnostics Incorporated has staked out the high ground. Its strategic obj…
Abbott Runs Into FDA Buzzsaw, Faces Major Marketplace Crisis
BY NOW, MOST OF THE clinical laboratory industry knows that Abbott Laboratories, Inc. signed a consent decree with the Food and Drug Administration (FDA) on November 2, 1999. Under terms of the consent decree, Abbott paid a $100 million fine and will pull a number o…
FDA Wants Abbott Labs To Toe Regulatory Line
CEO SUMMARY: In the short term, it’s Abbott Laboratories which must deal with increasingly aggressive FDA regulators. But the real story behind the story is that the FDA is stepping up regulatory oversight of the entire diagnostics industry. Abbott faces serious consequences if it canno…
Nichols Institute Earns ISO 9001 Certification
CEO SUMMARY: Although it’s the first ISO 9001-certified clinical laboratory in North America, Quest Diagnostics’ Nichols Institute is a late-comer to the party. Most major diagnostics companies already have ISO 9001 certification. This issue of THE DARK REPORT explores why Nichols’ …
Expect ISO 9000 To Alter Clinical Lab Management
CEO SUMMARY: Perceptive laboratory executives and pathologists should welcome the impending arrival of ISO 9000 into the clinical laboratory industry. It promises to solve many problems of laboratory management. The diagnostics industry, responsible for manufacturing instruments and suppl…
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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