TAG:
iso standard
Third Laboratory Earns ISO 15189 Accreditation
CEO SUMMARY: In June, the laboratory at Blanchard Valley Hospital became third in the nation to be accredited to ISO 15189:2007. The 150-bed acute facility in Findlay, Ohio, is the only hospital laboratory of its size to achieve accreditation to the ISO 15189 standard. Implementi…
Accreditation with DNV Helps Hospital Raise Inpatient Volume
CEO SUMMARY: In Utica, New York, 201-bed St. Elizabeth Medical Center was the first hospital in New York State and one of the first five hospitals nationwide to meet the new accreditation standard from DNV Healthcare, of Cincinnati, Ohio. St. Elizabeth administrators credit use o…
Quest’s Deficiencies Trigger QA/QC Questions
CEO SUMMARY: Experts in laboratory QA/QC and proficiency testing (PT) are following the news that Quest Diagnostics admitted to an 18-month problem with lab test accuracy in its home brew Vitamin 25(OH) D assay. It is recognized as a major failure in the existing system of labora…
2008’s Top Ten Lab Stories Lacked Disruptive Impact
CEO SUMMARY: For the first time in recent memory, a year has passed without major tumult or disruptive change in the laboratory industry. Our list of the Top Ten Most Important Stories of 2008 reflects a rather quiet year when compared to most years of this decade. Howeve…
Piedmont Med Lab Mixes ISO with Lean & Six Sigma
CEO SUMMARY: Piedmont Medical Laboratory (PML) could be the only clinical laboratory ever to pursue three quality improvement initiatives simultaneously. Even as it was in the early stages of implementing both Lean and Six Sigma methods, PML also decided to seek ISO 15189:2007 accreditati…
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…
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…
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…
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…
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…
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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