TAG:
quality management
ISO 15189 Is the Goal at Avera McKennan Lab
By Robert Michel | From the Volume XV No. 12 – September 8, 2008 Issue
CEO SUMMARY: Now entering its ninth month on the path to accreditation under ISO 15189:2007 Medical Laboratories, Avera McKennan’s lab recently completed its “gap analysis.” This important step prepared the laboratory for the pre-assessment and assessment steps that will result in a…
Two Healthcare Trends Collide on These Pages
By R. Lewis Dark | From the Volume XV No. 11 – August 18, 2008 Issue
THIS ISSUE OF THE DARK REPORT YOU NOW HOLD IN YOUR HANDS demonstrates the perfect intersection of two trends. One trend, transparency in health outcomes and a public expectation of reduced medical errors, is a direct threat to laboratories which fail to deliver high-quality and accur…
First U.S. Labs Nearing ISO:15189 Accreditation
By Robert Michel | From the Volume XV No. 11 – August 18, 2008 Issue
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
By Robert Michel | From the Volume XV No. 8 – June 16, 2008 Issue
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…
Implementing Best Practices Across 27 Hospital Labs
By Robert Michel | From the Volume XV No. 6 – May 5, 2008 Issue
CEO SUMMARY: It is always challenging to ensure consistency and high productivity across the different labs in a consolidated lab organization. To help staff focus on quality and efficiency, Alverno Clinical Laboratories LLC uses Lean methods to improve quality and timely delivery of lab …
Quality Guru Joseph M. Juran Dies Six Weeks Ago at Age 103
By Robert Michel | From the Volume XV No. 5 – April 14, 2008 Issue
HE DESCRIBED THE 20TH CENTURY as the Century of Productivity and expected the 21st Century to be the Century of Quality. Noted quality guru and management consultant Joseph M. Juran, Ph.D., died in his home in Rye, New York, on February 28 at the age of 103. Juran was the second seminal figure in th…
Ascendium Consulting Is New Firm In Lab Market
By Robert Michel | From the Volume XV No. 4 – March 24, 2008 Issue
CEO SUMMARY: Growing numbers of laboratories are taking steps to reengineer work flow, evaluate automation solutions, and improve the operational performance of their laboratory. This is fueling a demand for laboratory consulting services and Ascendium Consulting is this newest healthcare…
ISO 15189 Accreditation Program Offered by CAP
By Robert Michel | From the Volume XV No. 3 – March 3, 2008 Issue
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 …
Powerful Trends Reshaping Anatomic Path Profession
By Robert Michel | From the Volume XV No. 2 – February 11, 2008 Issue
CEO SUMMARY: THE DARK REPORT presents its newest biannual review of macro trends reshaping the anatomic pathology profession. These macro trends reveal a profession undergoing change and transformation on multiple fronts. New competitors are crowding into the market, payers and accreditin…
New Study Demonstrates How Lean Labs Outperform Peers
By Robert Michel | From the Volume XV No. 1 – January 21, 2008 Issue
CEO SUMMARY: A new study provides powerful evidence that laboratories using Lean, Six Sigma, and similar process improvement methods consistently outperform conventionally managed laboratories. Using data sets from 100 laboratories, including 14 Lean/Six Sigma laboratories, consultant Tho…
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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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