quality management systems Archives

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quality management systems

CMS Report, News Stories Describe Pathology Issues

By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue

CEO SUMMARY: In response to information the pathology lab staff provided to the hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, the Wake Forest Baptist Medical Center is taking corrective action to fix serious…

New Business Models for Pathology, Clinical Labs

By R. Lewis Dark | From the Volume XXIV No. 7 – May 15, 2017 Issue

EXPERTS OFTEN PROCLAIM THAT THE U.S. HEALTHCARE SYSTEM is slow to change and slow to adopt the management approaches, operational innovations, and new technologies that other industries use. One example is adoption of the quality management techniques that W. Edwards Deming and the Japanese develope…

ARUP Laboratories Earns CAP’s ISO 15189 Accreditation

By Joseph Burns | From the Volume XXIV No. 5 – April 3, 2017 Issue

CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…

October 13, 2014 “Intelligence: Late-Breaking Lab News”

By Robert Michel | From the Volume XXI No. 14 – October 13, 2014 Issue

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

By Joseph Burns | From the Volume XXI No. 5 – April 7, 2014 Issue

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…

Quality Assurance Regs to Tighten for UK Labs

By Robert Michel | From the Volume XXI No. 2 – February 3, 2014 Issue

CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…

Labs Push to Cut Costs As Budgets, Prices Shrink

By Robert Michel | From the Volume XX No. 11 – August 13, 2013 Issue

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

By Robert Michel | From the Volume XIX No. 18 – December 31, 2012 Issue

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. …

Lab Testing, Pathology Is Fast-Growing in China

By Robert Michel | From the Volume XVIII No. 15 – November 7, 2011 Issue

CEO SUMMARY: It was record attendance at the major pathology congress which took place in Hangzhou, China, last month. Because of the ongoing growth of China’s economy, the demand for healthcare—and for high-quality clinical lab and pathology testing—is rising at an accelerated pace…

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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