TAG:
proficiency testing
Laboratory Industry Has “Elephant in the Room”
CEO SUMMARY: In almost every laboratory across the United States and in several countries around the globe, one much-discussed topic in recent weeks has been the Vitamin D testing program deficiencies at Quest Diagnostics Incorporated. Yet, even as rank and file laboratorians act…
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…
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…
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 …
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…
Labs in British Columbia Meet Tough PT Standards
CEO SUMMARY: Facing a crisis due to several highly publicized deficiencies in lab testing, pathologists in Canada are using proficiency testing (PT) to improve standards. In British Columbia, PT is mandatory and every lab is evaluated every quarter. Pathologists in BC recommend that every…
Two Healthcare Trends Collide on These Pages
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
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…
Canadian Pathologists Start PT Testing for ER/PR
CEO SUMMARY: Experts point out that widely publicized episodes of lab testing deficiencies in several provinces are signs that chronic underfunding of lab testing services is a key factor in these failures. To restore public confidence in breast cancer testing, the Canadian Association of…
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…
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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