TAG:
quality system
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 …
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 …
Christian Hospital Laboratory Goes Lean with Solid Results
CEO SUMMARY: As part of a major restructuring program under way at Christian Hospital in St. Louis, Laboratory Administrator Bette J. Stanley decided to apply Lean quality management methods in projects to improve work processes in phlebotomy and the chemistry department. Using internal q…
Sonora Quest Receives Highest AZ Quality Award
CEO SUMMARY: After several years of intense effort to implement quality management systems and Six Sigma techniques throughout its organization, Sonora Quest Laboratories earned the Arizona Quality Program’s highest honor—the Governor’s Award for Quality. This is an accomplishment w…
For Quest and LabCorp, The Story is “Molecular”
CEO SUMMARY: Wall Street likes the potential of molecular diagnostics to infuse new revenues and operating profits into the laboratory industry. That is one reason Quest Diagnostics Incorporated and Laboratory Corporation of America are assertively seeking exclusive access to new molecula…
Pinkus DermPath Earns ISO-9000 Certification
CEO SUMMARY: After learning about quality management systems at a recent Executive War College, the lab director at Pinkus Dermatopathology recognized how such techniques could be used in his lab to improve quality, reduce errors, and create a better working environment for both pathologi…
Abbott Acquires I-Stat, Resolves FDA Problems
CEO SUMMARY: On December 15, Abbott revealed that it would pay $392 million to acquire I-Stat. Days later, on December 18, Abbott disclosed that the FDA had deemed its Lake County, Illinois diagnostic manufacturing plant to be “in substantial conformity” with the Quality System Regula…
How “Lean” is Benefiting Early-Adopter Laboratories
CEO SUMMARY: First steps toward a radical change in clinical laboratory operations are under way in a handful of early-adopter laboratories. This movement is so new that little information about their successes can be published. But the early evidence is compelling. For those labs willing…
Major Events Hit Pathology Profession
ACROSS THE AMERICAN HEALTHCARE SYSTEM, numerous trends tug at pathologists and the laboratory medicine services they provide. Both clinical pathologists and anatomic pathologists find themselves confronted with a growing number of demands for change. Increasingly these demands can no longer be ignore…
Gauging The Impact Of Lab Patient Safety
CEO SUMMARY: Within 18 months, the Laboratory Quality Institute plans to issue a national report on the quality of laboratory services. Not only will this bring a new level of public attention and scrutiny to clinical laboratory operations, but it will require everyone involved in deliver…
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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