TAG:
qms
October 13, 2014 “Intelligence: Late-Breaking Lab News”
Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The r…
CMS Gives Deemed Status to A2LA under CLIA Law
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
New ISO 15189 Book Published to Help Clinical Lab Managers
THERE IS NOW A COMPREHENSIVE GUIDE for lab executives and lab managers interested in learning more about ISO 15189:2012, the latest version of the quality management system (QMS) for medical laboratories. It is a book titled: “A Practical Guide to ISO 15189 in Laboratory Medicine” and was publis…
Lean Used to Lay Groundwork for Lab’s 15189 Accreditation
CEO SUMMARY: Henry Ford Health System’s laboratory organization has become first in the nation to have all its laboratory sites “standardized under one source of leadership” and accredited to the standards of ISO 15189: Medical Laboratories. The journey to achieve this current state…
Labs Push to Cut Costs As Budgets, Prices Shrink
CEO SUMMARY: Cost-cutting is now the prime directive at progressive labs because nearly every laboratory organization in the United States is under sustained financial pressure. This is due to shrinking budgets for hospital labs and more aggressive price-cutting by private payers. Even Ob…
2012’s Top Ten Lab Stories Predict More Challenges
CEO SUMMARY: It’s been a year with more lows than highs, when viewed through the lens of THE DARK REPORT’S “Top Ten Lab Stories of 2012.” The end of the TC grandfather clause, new policies for prostate biopsy billing, and a dramatic 52% cut to 88305- TC fees were widely reported. …
First-Mover Labs Reveal Success with Lean & QMS
CEO SUMMARY: There is good news for those clinical labs and pathology groups currently operating robust Lean, Six Sigma, and process improvement programs. The Institute of Medicine’s new report calls for all healthcare providers to rapidly transform themselves into ‘continuously learn…
Process Improvement Coming to Healthcare
CEO SUMMARY: One new byword coming to healthcare in the United States is the “continuously-learning healthcare system.” At the upcoming Lab Quality Confab in San Antonio next month, lab managers and pathologists can learn more about how to achieve and sustain continuous improvement in…
Ohio Lab Offers Lessons Learned from CAP 15189
CEO SUMMARY: For a lab looking to continually improve lab operations, becoming accredited to either ISO 15189 or CAP 15189 is an ideal challenge. After hearing from other lab directors about the benefits of becoming accredited to CAP 15189, the staff at Mercy Medical Center in Canton, Ohi…
QMS Helps Ontario Labs Cut Errors, Improve TAT
CEO SUMMARY: In Brampton and Etobicoke, Ontario, the hospital laboratories of William Osler Health System are using the quality management system of ISO 15189 to stay ahead of two powerful trends. Combining the QMS with Lean methods allows the labs’ management and staff to continuously …
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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