TAG:
lab quality
ISO 15189 Accreditation Requires Specific Steps For Global Recognition
CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…
DNV Offers Accreditation For Both CMS and ISO
CEO SUMMARY: For about a year, hospitals and health systems have had a new choice for meeting the Medicare Conditions of Participation. This new choice is Det Norske Veritas (DNV). Because DNV offers a dual process for achieving Medicare accreditation and ISO 9001 certification, it brings…
Expert Says Time is Now For Labs to Adopt QMS
CEO SUMMARY: Laboratories in the United States are knowledgeable about the use of quality control (QC) and quality assurance (QA) programs. But QC and QA represent only two small parts of a comprehensive quality management system (QMS), says Lucia Berte, an expert in lab quality. One bene…
Using Lean at Henry Ford Transforms Pathology TAT
CEO SUMMARY: Long-standing work flow traditions in anatomic pathology provide fertile ground for improvement with Lean and similar process improvement methods. That was the case at Henry Ford Health System, where empowered teams in the pathology laboratory employed the principles…
June 29, 2009 “Intelligence: Late Breaking Lab News”
In recent weeks, the laboratory at Blanchard Valley Hospital in Findlay, Ohio, received its accreditation for ISO 15189: Medical Laboratories. With this achievement, Blanchard Valley becomes only the third lab in the United States to become ISO 15189-accredited. Blanchard Valley’s …
When Does Cost Cutting Affect a Lab’s Quality?
CEO SUMMARY: Many lab professionals note the irony that a laboratory so publicly committed to Six Sigma quality management methods is now identified with the single largest episode of systemic failure in lab test accuracy. Looking in from the outside, some pathologists suggest th…
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…
Cytology Lab Uses Lean to Simplify Processes
CEO SUMMARY: Like many labs today, the gynecologic cytology laboratory at the University of Iowa Hospitals and Clinics had a pre- and post-analytical work flow with many complex steps. This work flow—heavily influenced by a legacy of previous information systems—was inefficient, conta…
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…
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 …
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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