TAG:
iso 9001
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…
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…
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…
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…
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…
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…
“December 22, 2003 Intelligence: Late Breaking Lab News”
Two more not-for-profit hospitals received the Malcolm Baldridge National Quality Award last month. St. Luke’s Hospital in Kansas City, Missouri and Baptist Hospital in Pensacola, Florida become the second and third hospitals to receive this award for quality achie…
“February 18, 2002 Intelligence: Late Breaking Lab News”
Lab execs and pathologists should pay close attention to this fact: Internet use by Americans significantly increased again last year. The Commerce Department reported that. as of September, 143 million people in the U.S. were using the Internet. This is 54% of the population and rep…
ISO 9000 Growing Across Lab Divisions of Quest Diagnostics
CEO SUMMARY: Currently the American healthcare system is struggling to evolve away from its “cottage industry” roots and adopt modern corporate management methods. Within the clinical laboratory industry, Quest Diagnostics Incorporated has staked out the high ground. Its strategic obj…
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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