TAG:
quality management
Staunch Laboratory Advocate Retires After 31 Years of Service
LAST MONTH, THE LABORATORY INDUSTRY lost one its most dedicated, full-time advocates. With his retirement in January, Joe Boone, Ph.D., ended a 31-year career with the Centers for Disease Control and Prevention (CDC). Boone started with the CDC in 1977. In 1992, he …
Labs Need to Respond To Inaccurate Results
CEO SUMMARY: What does a lab do when it discovers that it has reported inaccurate test results? In 2004, a turnaround team arrived at the laboratory of Maryland General Hospital in Baltimore to deal with the consequences of a failed infectious disease testing program. For about t…
Retest Program Offers Useful Lessons for Labs
CEO SUMMARY: Every day in every laboratory, there is the potential for some aspect of the testing process to go wrong and not be immediately detected. In such circumstances, the lab can then unknowingly report inaccurate test results to physicians and patients. That is why lab managers sh…
Quest Discusses Use of Mass Spec Methodology
CEO SUMMARY: Having made the decision to perform nearly all Vitamin 25(OH) D testing by liquid chromatography–tandem mass spectrometry (LC–MS/MS), Quest Diagnostics Incorporated found the transition to be challenging. That was particularly true as the volume of Vitamin D specimens tri…
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…
Current Review of CLIA Standards Intended to Address Laboratory PT
EFFORTS ARE UNDER WAY TO REVIEW existing requirements for laboratory certification under the federal Clinical Laboratory Improvement Act (CLIA). CLIA legislation was a response by Congress to widely-publicized failings in the quality and performance of certain cytology and office laboratories during …
Lean Six Sigma Takes Root in Labs & Hospitals
LAST WEEK, MORE THAN 300 ENTHUSIASTIC LAB AND HOSPITAL PROFESSIONALS from 11 different countries around the globe crowded into Atlanta for the Second Annual Lab Quality Confab. They were gathered to hear the latest success stories and breakthroughs in how laboratories and hospitals are using quality …
Two U.S. Labs Pursuing ISO 15189 Accreditation
CEO SUMMARY: In their first public interviews, the nation’s only two laboratories to seek ISO 15189:2007 accreditation share insights about the process, along with its challenges and benefits. Both laboratories are in the final stages of implementation and expect to earn accreditation b…
Quality Management Systems (QMS) & Healthcare
OFF THE RADAR SCREEN OF THE LABORATORY INDUSTRY is an evolving management approach that gives unity to the mishmash of quality improvement tools that carry a variety of names, but have several common attributes. Soon lab directors and pathologists will be quite familiar with the concept of the “qu…
ISO 15189 Is the Goal at Avera McKennan Lab
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…
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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