TAG:
laboratory accreditation
Explaining Certification Versus Accreditation
CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO). Many hospitals and clinic…
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…
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 …
Accreditation with DNV Helps Hospital Raise Inpatient Volume
CEO SUMMARY: In Utica, New York, 201-bed St. Elizabeth Medical Center was the first hospital in New York State and one of the first five hospitals nationwide to meet the new accreditation standard from DNV Healthcare, of Cincinnati, Ohio. St. Elizabeth administrators credit use o…
Inaccurate Lab Results: What Happened in Canada?
MANY OF YOU HAVE HEARD ABOUT THE WIDELY-PUBLICIZED PROBLEMS with laboratory testing in several locations across Canada in the past few years. We update the situation with a fascinating intelligence briefing on pages 9-12. The first lab scandal to catch the public’s attention was the discovery that…
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…
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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