TAG:
medical laboratories
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…
The Curious Case of Dr. Cockerill, Mayo Clinic and Quest Diagnostics
MOST PEOPLE WOULD CONSIDER the job of Chairman of the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic and CEO of Mayo Medical Laboratories (MML) to be at the pinnacle of the pathology profession. This makes it all the more curious as to why pat…
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…
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
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…
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…
March 17, 2014 “Intelligence: Late Breaking Lab News”
People walking down a street in Weatherford, Connecticut on March 10, found lab test reports for at least 16 patients, according to a news report by a local television news station. This is a breach of protected health information (PHI) under the federal HIPAA statute. Reporters from WSFB contacted o…
Eastern Canada’s Latest Lab Errors Get Attention
CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved q…
February 24, 2014 “Intelligence: Late Breaking Lab News”
Maybe the tough financial environment here in the United States is causing Sonic Healthcare Ltd., one of this nation’s bigger lab players, to be more interested in overseas lab testing opportunities. On February 18, its CEO, Colin Goldschmidt, M.D., told investors that “We contin…
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 …
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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