TAG:
quality assurance
UMass Lab’s Experience With Vitamin D Methods
CEO SUMMARY: As it developed a home brew mass spec assay for Vitamin 25(OH) D to meet the request of some client physicians, the laboratory at the University of Massachusetts Medical Center quickly recognized several challenges. First, there were fundamental differences in the nu…
ER/PR Testing in Canada Continues to Make News
CEO SUMMARY: In Canada, the story about inaccurate breast cancer testing just won’t go away. In March, the Cameron Report was made public with its assessment of lab testing failures in Newfoundland and Labrador. In April, the health system in those provinces admitted that it ne…
Kaiser in Colorado Uses Lab Test Data to Improve Cardiac Care
CEO SUMMARY: Proud of a 73% reduction in mortality among patients with coronary artery disease (CAD) at Kaiser Permanente Colorado, clinical care teams there demonstrate how integrated care and more effective use of laboratory test data can lead to remarkable improvements in pati…
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…
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 …
Inaccurate Results + Quest Dominates News Cycle
CEO SUMMARY: Most laboratory professionals don’t know it yet, but significant changes occurred to the entire lab industry last week. After Quest Diagnostics Incorporated acknowledged that it was retesting tens of thousands of patients because 7% of the Vitamin D results it repo…
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…
ASCP Awarded PEPFAR II Funds for Lab Assistance
CEO SUMMARY: With new Congressional authorization and funding of $48 billion, PEPFAR II—a second five-year initiative to help targeted countries battle HIV, AIDs, tuberculosis, and malaria—is about to get under way. To better support diagnosis and management of HIV/AIDs patie…
Siemens, BioImagene, Clarient University of Pennsylvania, Mayo Clinic
SIEMENS INVESTS IN DIGITAL PATHOLOGY, BUYS STAKE IN BIOIMAGENE IMAGING AND RADIOLOGY GIANT SIEMENS just made an interesting investment in digital pathology systems. On October 16, Siemens Venture Capital (SVC) revealed that it had purchased…
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…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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