TAG:
medical lab
May 19, 2014 “Intelligence: Late Breaking Lab News”
How about a hospital that doesn’t have a medical laboratory but issues lab test reports to patients? This unusual development happened in India recently. The Free Press Journal of Mumbai, India, reported earlier this month that government health officials had conducted a surprise inspectio…
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…
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…
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…
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 …
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…
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…
Across the Pond, Lots of Changes in Lab Testing
IN BOTH THE UNITED KINGDOM AND EUROPE, plenty of change is unfolding in clinical laboratory and anatomic pathology testing. Our intrepid Editor-in-Chief, Robert L. Michel, spent last week in England attending our annual Frontiers in Laboratory Medicine conference, now in its eleventh year. …
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…
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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