TAG:
testing laboratories
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…
Better Data Needed to Support Pathologists as Consultants
MULTIPLE TRENDS ARE UNFOLDING that mutually reinforce the need for pathologists and PhDs to be experts and consultants in how physicians order and follow up on molecular diagnostics assays and genetic tests. “Healthcare in the United States is approaching a tipping point that can greatly favor pat…
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 …
Reporters & Investigators Target Fraud in Pain Management Market
PAIN MANAGEMENT IS COMING under increased scrutiny by law enforcement officials and government regulators. Even the national media have begun to notice the fraud and abuse that is rampant in this rapidly-expanding sector of healthcare. Many pathologists and clinical laboratory managers will welcome …
In Massachusetts, AG Targets Drug Testing Labs
CEO SUMMARY: Since taking office in 2007, Massachusetts Attorney General Martha Coakley has aggressively pursued civil charges against drug testing labs. Last month, Coakley announced a criminal arrest in one ongoing investigation after a grand jury indicted a physician in a kick…
Consequences of Underfunding Lab Test Services
HOW LONG CAN IT TAKE FOR A HEALTHCARE SYSTEM to underfund clinical lab testing and anatomic pathology services before this ongoing financial erosion becomes visible in the form of systemic quality problems with lab tests? I believe the United States is now on the path to learning the answer to this …
Many Questions About FDA Regulation of LDTs
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
April 19, 2010 “Intelligence: Late Breaking Lab News”
Laboratory testing in India continues to attract the attention and investment dollars of western companies. News reports indicate that Apax Partners is negotiating to buy a stake in Metropolis Healthcare of Mumbai, India. Metropolis Healthcare has business activities…
ISO 15189 Accreditation Requires Specific Steps For Global Recognition
CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…
Two New Pathology Models Will Soon Be Tried in Dallas
CEO SUMMARY: There are notable aspects to how and why four unlikely partners are banding together to invest $40 million and create the nation’s newest reference and esoteric testing laboratory. It was the pathologists at Baylor University Hospital in Dallas, Texas, who originated the vi…
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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