TAG:
laboratory accreditation
Achieving CLIA, ISO 15189 at Same Time with A2LA
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
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…
July 21, 2014 “Intelligence: Late Breaking Lab News”
Consolidation of private pathology group practices continues. On July 8, NeoGenomics of Fort Myers, Florida, announced that it had acquired Path Logic of Sacramento. Then, one day later, Incyte Diagnostics of Spokane, Washington, disclosed that it wa…
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…
Caris Life Sciences Achieves Accreditation to ISO 15189
IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation. It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the …
Quality Assurance Regs to Tighten for UK Labs
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…
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…
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 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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