TAG:

laboratory quality management

Lean Used to Lay Groundwork for Lab’s 15189 Accreditation

CEO SUMMARY: Henry Ford Health System’s laboratory organization has become first in the nation to have all its laboratory sites “standardized under one source of leadership” and accredited to the standards of ISO 15189: Medical Laboratories. The journey to achieve this current state…

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Analysis of Lab Test Error Offers Lessons for Labs

CEO SUMMARY: As happens now and again, a rather typical example of an error in lab testing has made the nightly news in Indianapolis because of one justifiably irate patient who got a false positive test report for an STD. One pathologist, asked by THE DARK REPORT to assess the p…

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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…

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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…

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