TAG:
15189 accreditation
Our Top Ten Lab Stories Highlight Major Changes
CEO SUMMARY: What makes 2010 a watershed year for the laboratory testing industry is enactment of the 2,700-page Patient Protection and Affordable Care Act (PPACA). Even if parts of this bill are repealed, the remaining parts of the massive legislation will trigger major changes …
Quality Strategy Earns Honor for SD Laboratory
CEO SUMMARY: Here’s a new lab product launch with a surprise twist. Upon earning FDA clearance for its new HIV Ag/Ab Combo Assay this spring, Abbott Diagnostics selected a hospital laboratory in Sioux Falls, South Dakota, to be the nation’s first clinical lab to offer the ass…
ISO 15189 Accreditation Earned by Spectra Labs
CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. …
Third Laboratory Earns ISO 15189 Accreditation
CEO SUMMARY: In June, the laboratory at Blanchard Valley Hospital became third in the nation to be accredited to ISO 15189:2007. The 150-bed acute facility in Findlay, Ohio, is the only hospital laboratory of its size to achieve accreditation to the ISO 15189 standard. Implementi…
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 …
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…
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…
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…
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…
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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